The QP Diaries, by AssureBio

Step inside the real journey to becoming a Qualified Person (QP) — the emotional highs, the setbacks, the VIVA pressure, and the diverse paths that lead to one of pharma’s most respected roles. In this deep dive, we share real stories from QPs, assessors, and trainees — revealing what it actually takes to qualify, what makes candidates stand out, and why the QP role is far more than just technical knowledge. Whether you’re preparing for QP training, exploring a QA career, or fascinated by pharmaceutical quality, this episode will give you rare insights you won’t find in textbooks.-------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

The 3 Golden Threads: Lessons from 21 QPs is an exclusive 10-minute bonus for the early launch group. Drawn from years of conversations, it explores resilience, leadership, and patient focus, the timeless lessons every QP needs. A glimpse of what’s to come in The PlaybookUnlock the 3 Golden Threads shared by 21 Qualified Persons—powerful insights that every aspiring or current QP, QA professional, and pharma leader should know. In this exclusive Deep Dive from QP Diaries: The Playbook, we break down what truly matters: resilience for the QP viva, authentic leadership, collaboration, and the unshakeable focus on patient safety.Whether you're preparing for your QP viva, planning your QP career path, or leading in pharmaceutical quality assurance, these lessons will transform how you grow, lead, and make critical quality decisions------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

Dive into the ultimate collection of QP wisdom—distilled from 21 world-class Quality leaders across the pharmaceutical industry. Whether you're preparing for your QP Viva, navigating GMP compliance, building a quality culture, or stepping into pharma leadership, this video breaks down the most powerful lessons shared on The QP Diaries: The Playbook. Perfect for aspiring QPs, QA professionals, and anyone shaping patient-centric decisions in the Life Sciences. ------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

AI is reshaping pharmaceutical Quality Assurance faster than ever — from batch release to deviation investigations to QP training. In this deep-dive, we unpack insights from leading voices in pharma QA and QP development, exploring the real impact of AI, the new skills QPs must build, and the regulatory gaps the industry urgently needs to address. If you're a Qualified Person, QA Manager, Quality Leader, auditor, or aspiring QP, this is your shortcut to staying ahead of the biggest shift in GMP, compliance, and pharmaceutical manufacturing.------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

In this Deep Dive, we unpack the human side of pharmaceutical Quality Assurance — from building high-performing QA cultures to coaching future QPs, handling pressure, leading through change and preparing for AI-driven quality systems. Drawn from candid interviews with Qualified Persons (QPs) and senior QA leaders across the UK pharma industry, this episode delivers real-world insights on leadership, resilience, quality culture, GMP decision-making, coaching, and the future of the QP role. If you’re a Quality Director, Senior QA Leader, or aspiring QP, this is your essential playbook for leading people, shaping culture, and staying ahead of the industry's biggest changes. ------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

This episode dives deep into how GMP pharmaceutical facilities are really built, featuring real stories and insights from Qualified Persons (QPs) and Quality leaders who have led new site builds, scale-ups, aseptic expansions, and MHRA inspections. If you work in QA, QC, Validation, ATMPs, sterile manufacturing, or are on the QP pathway, this is your shortcut to understanding the risks, pitfalls, timelines, culture challenges and inspection readiness strategies behind a successful GMP facility launch. You’ll learn about: • QP leadership during GMP builds • MHRA licensing mistakes to avoid • Environmental monitoring, qualification, validation • Post-licence optimisation realities • QA culture, team building & tech adoption (LIMS, MES, AI) Perfect for aspiring QPs, QA professionals, and anyone preparing for GMP site builds, facility expansion, or MHRA inspection readiness.------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

Learn what really happens when a pharma quality crisis hits. In this QP Diaries deep-dive, we explore how Qualified Persons (QPs) lead GMP remediation, restore MHRA/FDA compliance, fix systemic quality failures, and rebuild a strong quality culture under extreme pressure. Featuring insights from leading QPs in the UK pharmaceutical industry, this episode breaks down the real triggers behind quality system breakdowns, regulatory findings, amber-light warnings, culture issues, CAPA failures, and what it takes to successfully steer a company through remediation. ------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

Discover the REALITY of becoming a Qualified Person (QP) — the training, the viva, the failures, the crises, and the leadership journey. This deep dive reveals true stories from AssureBio’s QP Diaries archive: batch release challenges, high-stakes decisions, QP mindset, resilience, quality culture, and how QPs evolve across decades. Whether you're an aspiring QP, a QA professional, or leading Quality teams in pharma, this episode breaks down: ✔ How QPs get started ✔ The gruelling QP training journey ✔ Viva exam strategies ✔ Real GMP crises (including site fires, deviations & million-pound batch rejections) ✔ Leadership evolution for modern QPs ✔ AI, ATMPs & the future of pharmaceutical Quality ------------------📘Download The QP Diaries: The PlaybookLearn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.👉 Download now: https://bit.ly/49zZ2F1------------------How Strong Is Your Hiring Strategy? Assess your recruitment strategy and get practical advice to attract, secure, and retain the very best Global Quality professionals. •Uncover hidden gaps slowing down your hiring •Benchmark your process against best-in-class recruitment practices •Get tailored, actionable recommendations you can use immediately 📝Start your Recruitment Health Check! https://bit.ly/4o37Tm9------------------About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise. Contact us:🌐 www.assure-bio.com📧 [email protected]

What happens when someone outside of QA gets the chance to step up as a Qualified Person? In this episode of The QP Diaries, we sit down with Graham Clarke, a seasoned pharmaceutical professional whose 20+ year journey spans sterile manufacturing, solid dosage forms, and cutting-edge cell and gene therapy. Graham shares his unexpected path into QA and how he seized the opportunity to become a QP at Baxter—despite not coming from a traditional Quality background. He walks us through the realities of preparing for and sitting the VIVA, offering practical insight for Trainee QPs and those navigating their own journey. Now working as a QP Consultant, Graham candidly reflects on why he chose to go independent, the challenges he’s faced, and what he’s learned along the way. This episode is packed with real talk, hard-earned lessons, and a refreshing perspective on what it really takes to grow, adapt, and thrive as a QP in today’s pharmaceutical landscape. Whether you’re just starting your journey or leading at the highest levels, this career-focused conversation will give you the insight—and the reassurance—that there’s more than one path to a successful QP career.

In this episode of the QP Diaries, we’re joined by Adam Walker, the first NHS Qualified Person (QP) to appear on the podcast. Adam shares his personal journey to becoming a QP, how he tackled the VIVA (and what he’d do differently), and his pivotal role in leading development and innovation at the NENC Medicines Manufacturing Centre.We dive into how the NHS is transforming aseptic services across the region, the future role of AI in Quality Assurance, and the skills QPs will need moving forward. Adam also lifts the lid on Help Me GMP, the YouTube channel he co-hosts with Kyle Winn, which is making GMP training more accessible, practical, and powerful. you're a Trainee QP, experienced QA leader, or just curious about how NHS-led manufacturing is evolving, this episode is packed with insight, honesty, and forward-thinking.

In this episode of The QP Diaries, we’re joined by Stephen Clarke, newly appointed Head of Quality and Qualified Person at BDD. With decades of experience across diverse pharmaceutical environments and a proven track record leading global Quality functions, Stephen shares his unique journey, from his early days in food lab QC to becoming a QP responsible for complex clinical and commercial products. Stephen reflects on the formative years of his QP training, the value of cross-site exposure in sterile and OSD manufacturing, and the realities of batch certification in today’s evolving regulatory landscape. Now at BDD, he’s leveraging his deep GMP expertise to support cutting-edge radiolabelled medicines and same-day QP release, accelerating clinical insights and patient access. We explore the growing responsibility of QPs in shaping Pharmaceutical Quality Systems (PQS), the impact of AI on decision-making, and why strong communication is critical when working in contract manufacturing. Stephen also shares how he mentors the next generation of Quality professionals and the one piece of advice he’d give to his younger self. Whether you're a trainee QP, Quality leader, or simply curious about the human side of pharmaceutical compliance, this episode is packed with practical insights and leadership perspective.

In this episode of The QP Diaries, we’re joined by Damian Larrington — an experienced and eligible Qualified Person under 2001/83/EC and 2001/20/EC, with a background spanning aseptic, biologic, ATMP, IMP, terminally sterilised, and solid dose products.We explore Damian’s journey to becoming a QP, what it truly means to be “the right person” for the role, and how to balance study, work, and personal growth in a highly regulated environment. Damian shares practical insight on the importance of practicing difficult conversations, what QPs need to prepare for in an AI-driven global landscape, and the critical challenges facing today’s pharmaceutical quality professionals. Whether you're a trainee QP, seasoned professional, or just curious about the future of Quality, this episode is packed with perspective, honesty, and invaluable advice from one of the industry’s most grounded voices.

In this episode, Dal is joined by Marie, a distinguished Quality Professional whose career reflects decades of diverse experience across R&D, Regulatory Affairs, and Quality Assurance. From her early days as a QC Chemist to her most recent role as QP for sterile products, Marie shares candid reflections on embracing mistakes as powerful learning moments, staying open to new opportunities, and the discipline instilled through QP training. With experience spanning inhalation products, biologics, combination devices, and hosting inspections from global regulators like the FDA and HPRA, Marie brings a grounded yet inspiring perspective to professional growth. Whether you're at the beginning of your QP journey or navigating senior QA leadership, this episode offers valuable insights into resilience, continuous learning, and the mindset needed to thrive in pharma quality.

In this episode, Dal sits down with David Waddington, a true veteran of the pharmaceutical quality landscape, whose career spans over 30 years across global roles in QA, manufacturing, and regulatory compliance. From his first steps toward becoming a Qualified Person (QP) to leading international quality teams at major pharmaceutical organizations, Dave shares a career built on embracing opportunities, adapting to challenges, and mentoring the next generation of quality professionals. Now part of the team at NSF and formerly Quality Director, Global Regulatory Compliance at Catalent, Dave brings a wealth of insight into EU and FDA GMPs, auditing excellence, and international compliance. Whether you're an aspiring QP or a seasoned QA leader, this episode is packed with practical wisdom, candid reflections, and career-defining lessons.

What does it really take to become a Qualified Person—and feel confident in the role once you're there?In this episode of The QP Diaries, we’re joined by Vicky, an experienced Qualified Person, Quality professional, and NSF trainer with over 20 years in the pharmaceutical industry. Her career spans R&D, clinical trials, tech transfer, commercial manufacturing, and site closures—giving her a rare perspective on the full product lifecycle.Now supporting QP trainees through NSF’s training programme, Vicky shares practical advice and encouragement for those on the journey to becoming a QP.We discuss:The role of a QP in supporting and managing change within QA teams and operationsHow mind mapping can strengthen your VIVA preparationThe value of mock VIVA sessions—and how to make them countThe key qualities and skills that help QPs succeed in the real worldWhether you're preparing for your VIVA, building your confidence, or just exploring what the QP role involves, this episode is full of insight and real-world advice from someone who trains and mentors future QPs every day.

With over 16 years of pharmaceutical experience, Uche Ekwuozor is a Chartered Chemist, Chartered Scientist, and Qualified Person (QP) renowned for his deep expertise in sterile products, biologicals, and GMP compliance. From leading MHRA remediation projects to overseeing global quality operations at top pharmaceutical firms like BMS/Celgene and MSD Animal Health, Uche brings a wealth of insight into Quality Risk Management, QMS integration, and regulatory strategy.In this episode, we dive into Uche's impressive journey—from working across clinical and commercial manufacturing environments to becoming a key figure in shaping quality systems, coaching future QPs, and navigating complex audits and compliance challenges. A true advocate for operational excellence and continuous improvement, Uche shares valuable lessons and bold perspectives on what it takes to lead in pharmaceutical quality today.

Welcome to the QP Diaries podcast! In this episode, host Dal welcomes Catherine Kay from NSF, the new sponsor of the show. With over 20 years of experience in pharmaceutical operations management and technical QA, Catherine is also an eligible QP. Together, they explore the vital role of quality assurance in the pharmaceutical industry and the dedication required to become a Qualified Person (QP). Catherine also shares insights on people development and fostering learning organizations. Tune in for expert perspectives on the QP journey and the evolving landscape of pharmaceutical quality.Key Moments:[00:01:01] QP training and support.[00:04:57] Quality assurance career transition.[00:09:05] Career evolution and opportunities.[00:11:14] Importance of investing in people.[00:15:51] Employee investment benefits organizations.[00:18:10] Essential qualities for QPs.[00:25:03] Personal development and mentorship.[00:26:33] Evolving role of a QP.[00:31:25] Educating QPs of the future.[00:33:52] Trainee QP symposium networking.

In this episode of the QP Diaries podcast, host Dal interviews Mark King, who has over 30 years of experience in Quality based roles within the pharmaceutical industry. Mark is a Qualified Person under the permanent provisions since March 2001, and a former QP Assessor, Vice Chair and Chair of the Royal Society of Biology QP Assessors Panel.During the episode, Mark shares insights from his career journey and offers valuable advice to QPs and trainees. This includes sharing his best tips with trainees preparing for their VIVA, as well as rare insights into his experience as a panel assessor. The discussion also delves into mergers and acquisitions and managing site closures from a QP's perspective, giving important guidance for anyone wishing to further their understanding of the pharmaceutical sector.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal interviews Ilona, a newly qualified QP in the UK pharmaceutical industry. Ilona shares her journey from a background in microbiology to becoming a QP, discussing her experience in quality control and R&D roles in clinical and pharmaceutical settings. Tune in to gain insights into Ilona's career transition and valuable expertise as a qualified person.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar interviews Rebecca, a seasoned quality assurance professional and qualified person (QP) in the UK pharmaceutical industry. They discuss various aspects of Rebecca's career, including her journey as a QP, her expertise, and her accomplishments. The episode focuses on leadership, team collaboration, tools and methodologies used in quality assurance, and advice for aspiring QPs. Listeners will gain insights into the world of quality assurance and learn from Rebecca's experiences as a leader in the industry. Tune in to this inspiring episode to empower your career in quality assurance.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with guest is Phil Rose, who shares his personal experience of failing the Viva (oral examination) the first time and how he overcame it. Phil provides a brief overview of his career journey, starting from his early lab work to his training as a QP and eventually becoming an inspector at the MHRA (Medicines and Healthcare products Regulatory Agency). He also discusses his transition into consultancy and his passion for training and mentoring the next generation of QPs.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with a seasoned qualified person (QP) in the pharmaceutical industry. They discuss the guest's career journey and provide valuable advice for aspiring QPs. Additionally, they delve into the topic of working on remediation projects in the industry. With over 30 years of experience, the guest shares their insights and expertise, making this episode a must-listen for anyone interested in quality assurance and the pharmaceutical industry. Tune in to gain valuable knowledge and inspiration for your own QP career.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with qualified QP, Kevin Currie, from the pharmaceutical industry. They discuss the importance of inspiring and empowering the next generation of QPs and share their personal story and expertise. Kevin shares how their career started in a laboratory working with chemicals and how they learned critical thinking and problem-solving skills. Tune in to this episode to gain insights into the world of QPs and learn from industry thought leaders.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with qualified QP, Kevin Currie, from the pharmaceutical industry. They discuss the importance of inspiring and empowering the next generation of QPs and share their personal story and expertise. Kevin shares how their career started in a laboratory working with chemicals and how they learned critical thinking and problem-solving skills. Tune in to this episode to gain insights into the world of QPs and learn from industry thought leaders. Key moments 00:00:10 - Introduction to QP Diaries Podcast 00:00:52 - Inspiring the Next Generation of QPs 00:01:12 - Kevin's Career Beginnings 00:02:17 - Transition to the Pharmaceutical Industry 00:03:33 - Leadership and Management Lessons 00:05:36 - Becoming a Qualified Person (QP) 00:07:28 - Importance of Relationships for QPs 00:08:11 - The Viva Experience 00:09:00 - Career Progression Post-Qualification 00:10:02 - Contracting and Remediation Work 00:12:23 - Training and Mentoring 00:14:09 - Quality Culture and Senior Management 00:15:14 - Key Milestones and Learnings 00:17:23 - Empowering Team Members 00:19:10 - Communication and Building Relationships 00:21:16 - Leadership vs. Management 00:22:22 - Selecting the Right QP Candidates 00:23:47 - Collaboration and Managing Upwards 00:26:01 - Importance of Root Cause Analysis 00:28:45 - Empowering Others to Lead 00:31:17 - Managing Upwards and Assertiveness 00:33:08 - Building Relationships Across Departments 00:35:22 - The Future of the QP Role 00:37:01 - Advice to Younger Self 00:38:06 - Keeping Up with Changing Regulations 00:40:14 - Final Thoughts and Reflections 00:42:24 - Contact Information for Kevin 00:48:54 - Closing Remarks and Podcast Information

Welcome to the QP Diaries podcast! In this episode, our host Dal Pawar sits down with special guest Richard to discuss his journey to becoming a Qualified Person (QP) and his experiences as a QP sponsor and assessor. They also delve into Richard's leadership experience and how he manages stress in his role. Plus, they explore the fascinating topic of artificial intelligence and its impact on the pharmaceutical industry. If you're passionate about quality assurance and want to learn from industry experts, this is the podcast for you. Don't miss out on this insightful and informative episode!

Welcome to the QP Diaries podcast! In this episode, host Dal Pawar interviews Adrian Zahra, a quality assurance professional, about his career journey and experiences in the pharmaceutical industry. They discuss topics such as leadership strategies, collaboration, and work-life balance. If you're interested in quality assurance and want to learn from industry experts, this is the podcast for you. Adrian, a quality assurance professional, shares his career journey and experiences as a QP in this podcast episode. The conversation revolves around the importance of collaboration in quality assurance teams and departments. Adrian notes the growing complexity and responsibility of the QP role, making it crucial for teams to work together. Collaboration enables the sharing of expertise, building trust in team members' abilities, and effectively addressing issues. Adrian also emphasizes the need for QPs to establish trust with their team, encouraging timely escalation of critical matters.Tune in to gain inspiration and empowerment as you navigate your own career in the pharmaceutical industry.

In this episode of the QP Diaries Podcast, we dive into the future of quality assurance with a special guest Mukesh Patel. We discuss the importance of artwork origination, product recalls, and the importance of staying up-to-date and educated in this rapidly changing field. We also explore the value of building a professional QP network and how it can benefit your career.Host Dal Pawar speaks with Mukesh, who shares his non-traditional career path, starting from his passion for science as a teenager to his chemistry degree and research experience. They discuss the future of quality assurance and delve into Mukesh's experiences as a QP. Join us for an insightful conversation that will leave you inspired and ready to embrace the changes ahead. Don't miss out on this valuable discussion for anyone in the pharmaceutical and biotech industry.Key moments [00:01:09] The future of quality. [00:05:29] The Mars project. [00:09:03] Supply chain challenges in pharmaceuticals. [00:13:40] Artwork origination and product defects. [00:19:30] The importance of artwork. [00:24:03] Leadership development for QPs. [00:29:12] The role of AI in pharmaceuticals.

In this episode of the QP Diaries podcast, host Dal Pawar welcomes special guest Chris Howell to discuss the intricacies of obtaining a GMP license for a new build facility. They delve into the three important phases of leading a project of this nature. In addition, Chris shares valuable insights for aspiring QPs and how to balance risk when thinking about the end user. Dal Pawar speaks with Chris, a seasoned quality assurance professional with over 30 years of experience. Chris shares his career journey and expertise as a QP in the pharmaceutical industry. Listeners will gain insights into the world of quality assurance and learn from Chris' words of wisdom. If you're passionate about quality assurance and want to learn from industry experts, this episode is a must-listen. https://assure-bio.com/

In this episode of the QP Diaries podcast, host Dal interviews Mark King, who has over 30 years of experience in Quality based roles within the pharmaceutical industry. Mark is a Qualified Person under the permanent provisions since March 2001, and a former QP Assessor, Vice Chair and Chair of the Royal Society of Biology QP Assessors Panel.During the episode, Mark shares insights from his career journey and offers valuable advice to QPs and trainees. This includes sharing his best tips with trainees preparing for their VIVA, as well as rare insights into his experience as a panel assessor. The discussion also delves into mergers and acquisitions and managing site closures from a QP's perspective, giving important guidance for anyone wishing to further their understanding of the pharmaceutical sector. Key moments: [00:01:40] Managing site closures from a QP's perspective. [00:07:32] Guidance for trainee QPs. [00:10:21] Practical hands-on experience importance. [00:13:49] Common reasons for failure. [00:17:26] Practical experience for successful viva. [00:19:43] Standout Vivas and Memorable Experiences. [00:24:14] Importance of patient focus. [00:26:47] Mergers and acquisitions in pharmaceuticals. [00:31:39] Business Mergers and Acquisitions. [00:35:47] Learning from challenging experiences. [00:39:19] Continuous learning and growth. [00:41:55] Favorite part of QP role. [00:43:44] Passion for quality assurance work.

In this episode of the QP Diaries podcast, host Dal interviews Martin Lush, who has 40 years’ leadership experience in pharmaceutical and health care. Martin has held senior (Global VP) leadership positions in global consulting/training business, manufacturing, operations, supply chain and QA (regulatory compliance) - biotech (aseptic) products and is a ‘Qualified Person’ (QP) under permanent provisions.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal interviews Ilona, a newly qualified QP in the UK pharmaceutical industry. Ilona shares her journey from a background in microbiology to becoming a QP, discussing her experience in quality control and R&D roles in clinical and pharmaceutical settings. Tune in to gain insights into Ilona's career transition and valuable expertise as a qualified person. Key moments [00:03:44] Journey to becoming a QP. [00:05:38] Challenges in QP training. [00:09:16] Challenges during training. [00:14:04] Study planning for QPs. [00:20:34] Staying motivated in training. [00:23:31] Viva assessment experience. [00:29:54] Unusual QP exam dynamics. [00:35:28] Dealing with quality issues. [00:36:47] Networking advice for QPs.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar interviews Rebecca, a seasoned quality assurance professional and qualified person (QP) in the UK pharmaceutical industry. They discuss various aspects of Rebecca's career, including her journey as a QP, her expertise, and her accomplishments. The episode focuses on leadership, team collaboration, tools and methodologies used in quality assurance, and advice for aspiring QPs. Listeners will gain insights into the world of quality assurance and learn from Rebecca's experiences as a leader in the industry. Tune in to this inspiring episode to empower your career in quality assurance. Key moments [00:01:21] Leadership in quality assurance. [00:06:31] Collaboration within quality assurance teams. [00:09:01] Importance of effective communication. [00:14:00] Manufacturing suite challenges. [00:19:33] Trust and delivering for your team. [00:22:44] Navigating return to work. [00:27:23] Understanding AI and machine learning. [00:30:08] Integration in pharmaceutical manufacturing. [00:34:30] Implementing new technologies in industries. [00:39:02] Broadening Your Network. [00:45:36] Seeking career acceleration through mentors. [00:49:00] The value of quality professionals.

.. Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with guest is Phil Rose, who shares his personal experience of failing the VIVA the first time and how he overcame it. Phil provides a brief overview of his career journey, starting from his early lab work to his training as a QP and eventually becoming an inspector at the MHRA (Medicines and Healthcare products Regulatory Agency). He also discusses his transition into consultancy and his passion for training and mentoring the next generation of QPs. Key moments [00:01:17]: Mention of the Viva process and its difficulty. [00:05:41]: Importance of gaining diverse experience in the industry. [00:10:34]: Emotional impact of failing the Viva and thoughts of career uncertainty. [00:21:27]: Strategies for Viva preparation, including mock Vivas and support network. [00:29:01]: Importance of working towards solutions and seeking advice from inspectors. [00:30:32]: Importance of continuous learning and addressing knowledge gaps in the industry.

Welcome to the QP Diaries podcast! In this episode of the QP Diaries podcast, host Dal Pawar speaks with Robin Railton, a seasoned qualified person (QP) in the pharmaceutical industry. They discuss the Robin's career journey and provide valuable advice for aspiring QPs. Additionally, they delve into the topic of working on remediation projects in the industry. With over 30 years of experience, the guest shares their insights and expertise, making this episode a must-listen for anyone interested in quality assurance and the pharmaceutical industry. Tune in to gain valuable knowledge and inspiration for your own QP career. Key moments [00:01:12] Working on remediation projects. [00:05:02] Gaining breadth in experience. [00:15:06] Challenges in quality assurance. [00:16:46] Unhealthy norms in industry. [00:22:03] Open communication and transparency. [00:31:35] Being inspection ready. [00:34:05-00:34:15] Practical application for QPs. [00:39:16] Reflecting on risk-based decision making. [00:46:26] I love factories.

Welcome to the QP Diaries podcast! In this episode, our host Dal Pawar sits down with special guest Richard to discuss his journey to becoming a Qualified Person (QP) and his experiences as a QP sponsor and assessor. They also delve into Richard's leadership experience and how he manages stress in his role. Plus, they explore the fascinating topic of artificial intelligence and its impact on the pharmaceutical industry. If you're passionate about quality assurance and want to learn from industry experts, this is the podcast for you. Don't miss out on this insightful and informative episode! Key moments 00:00:10 - Introduction to QP Diaries Podcast 00:00:52 - Host Introduction and Guest Welcome 00:01:20 - Episode Topics Overview 00:02:07 - Guest's Industry Journey 00:04:13 - Experience Across Various Dosage Forms 00:07:22 - Role as a Contract QP 00:09:01 - Managing Stress and Work-Life Balance 00:10:17 - Advice for Trainee QPs 00:12:09 - Importance of a QP Sponsor 00:13:58 - QP Symposium Discussion 00:15:02 - Qualities of a Good Sponsor 00:16:10 - Viva and Decision-Making 00:17:04 - Role as a QP Assessor 00:18:01 - Leadership Experience 00:19:19 - Managing Career Progression and Burnout 00:20:27 - Advice to Younger Self 00:22:10 - Time Management and Prioritization 00:23:08 - Embracing Change and Challenges 00:24:09 - Transitioning to Leadership Roles 00:25:17 - Continuous Learning and Career Development 00:26:32 - Balancing Ambition and Well-being 00:27:07 - Leadership Qualities and Responsibilities 00:28:19 - Challenges of Senior Leadership Positions 00:29:31 - Leadership and Decision-Making Skills 00:30:24 - Aspiring to Leadership in the QP Role 00:31:33 - Personal Reflections on Leadership 00:32:43 - Considering Career Limits and Opportunities 00:34:02 - Work-Life Balance as a Senior Leader 00:35:34 - The Risks of Senior Management Roles 00:36:33 - Artificial Intelligence in QP Decision-Making 00:39:09 - Regulation and Guidance for AI in Pharma 00:40:03 - QP Symposium Agenda and AI Discussion 00:41:20 - Symposium's Value and Networking Opportunities 00:42:13 - Additional Symposium Features 00:42:50 - Closing Remarks and Contact Information 00:44:07 - Podcast Outro and Host's Company Promotion

Welcome to the QP Diaries podcast! In this episode, host Dal Pawar interviews Adrian Zahra, a quality assurance professional, about his career journey and experiences in the pharmaceutical industry. They discuss topics such as leadership strategies, collaboration, and work-life balance. If you're interested in quality assurance and want to learn from industry experts, this is the podcast for you. Adrian, a quality assurance professional, shares his career journey and experiences as a QP in this podcast episode. The conversation revolves around the importance of collaboration in quality assurance teams and departments. Adrian notes the growing complexity and responsibility of the QP role, making it crucial for teams to work together. Collaboration enables the sharing of expertise, building trust in team members' abilities, and effectively addressing issues. Adrian also emphasizes the need for QPs to establish trust with their team, encouraging timely escalation of critical matters. Tune in to gain inspiration and empowerment as you navigate your own career in the pharmaceutical industry. Key moments [00:01:50] Career journey as quality assurance professional. [00:06:41] Collaboration within quality assurance. [00:11:02] Reshaping an audit and regulatory compliance function. [00:14:36] Conflict and constructive resolution. [00:20:08] Becoming a Leader in Quality. [00:25:22] Moving ahead steadily. [00:29:38] Amputation vs. Antibiotic. [00:34:12] Managing stress and pressure. [00:39:36] Developing external interests. [00:42:30] Being liked 100% of the time.

In this episode of the QP Diaries Podcast, we dive into the future of quality assurance with a special guest Mukesh Patel. We discuss the importance of artwork origination, product recalls, and the importance of staying up-to-date and educated in this rapidly changing field. We also explore the value of building a professional QP network and how it can benefit your career. Host Dal Pawar speaks with Mukesh, who shares his non-traditional career path, starting from his passion for science as a teenager to his chemistry degree and research experience. They discuss the future of quality assurance and delve into Mukesh's experiences as a QP. Join us for an insightful conversation that will leave you inspired and ready to embrace the changes ahead. Don't miss out on this valuable discussion for anyone in the pharmaceutical and biotech industry. Key moments [00:01:09] The future of quality. [00:05:29] The Mars project. [00:09:03] Supply chain challenges in pharmaceuticals. [00:13:40] Artwork origination and product defects. [00:19:30] The importance of artwork. [00:24:03] Leadership development for QPs. [00:29:12] The role of AI in pharmaceuticals.

In this episode of the QP Diaries podcast, host Dal Pawar welcomes special guest Chris Howell to discuss the intricacies of obtaining a GMP license for a new build facility. They delve into the three important phases of leading a project of this nature. In addition, Chris shares valuable insights for aspiring QPs and how to balance risk when thinking about the end user. Dal Pawar speaks with Chris, a seasoned quality assurance professional with over 30 years of experience. Chris shares his career journey and expertise as a QP in the pharmaceutical industry. Listeners will gain insights into the world of quality assurance and learn from Chris' words of wisdom. If you're passionate about quality assurance and want to learn from industry experts, this episode is a must-listen. Key moments [00:02:43] QP training and qualification. [00:06:23] Nuclear medicine and challenges. [00:08:23] New site builds and approvals. [00:12:09] Major challenges in licensing. [00:17:29] Challenges in new builds. [00:19:12] Going too early risks delays. [00:23:07] Training nuclear medicine sites. [00:26:29] Incorporating different cultures in operations. [00:30:00] Building a strong leadership team. [00:34:39] Sterility event and accountability. [00:38:13] Balancing risk and patient care. [00:43:03] Quality assurance in biotech.

In this episode of the QP Diaries Podcast, we delve into the fascinating world of artificial intelligence (AI). Join us as we discuss the incentives of AI in the industry and explore its potential to transform the way we work. Our special guest, Phoebe Clough, shares her insights and experiences with AI, from utilizing virtual reality & augmented reality for L&D, to creating interactive chatbots for QPs. Host Dal Pawar speaks with Phoebe, a contract QP, about her career journey as a quality assurance and QP professional. Phoebe shares her expertise and experiences, highlighting the importance of continuous learning and growth in the pharmaceutical industry. Whether you're excited or fearful about AI, this episode will provide valuable perspectives and case studies to help you embrace the future. Tune in now and join the conversation on this fashionable subject! Key moments [00:02:17] Roller coaster journey to QP. [00:06:47] AI impacting the QP. [00:10:11] Utilizing simulator technology. [00:14:39] Virtual reality for training QPs. [00:19:09] AI democratizing learning and development. [00:25:29] Curiosity and interactive chatbots. [00:29:53] AI supporting job roles. [00:35:54] The role of a QP evolving. [00:38:21] The future of QP with AI.