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The QP Diaries, by AssureBio
Dal Pawar
32 episodes
6 days ago
The QP Diaries is brought to you by AssureBio. Our mission is to inspire and empower the next generation of QA professionals and future Quality Assurance leaders. If you're passionate about quality assurance and eager to learn from those in the industry, we'd be thrilled for you to subscribe and listen. 🌐 Website: www.assurebio.com 📧 Contact: dal@assurebio.com 📱 LinkedIn: https://www.linkedin.com/company/assurebio/ Let's together ensure quality assurance excellence in the pharmaceutical and biotech sectors, one podcast episode at a time!
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All content for The QP Diaries, by AssureBio is the property of Dal Pawar and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
The QP Diaries is brought to you by AssureBio. Our mission is to inspire and empower the next generation of QA professionals and future Quality Assurance leaders. If you're passionate about quality assurance and eager to learn from those in the industry, we'd be thrilled for you to subscribe and listen. 🌐 Website: www.assurebio.com 📧 Contact: dal@assurebio.com 📱 LinkedIn: https://www.linkedin.com/company/assurebio/ Let's together ensure quality assurance excellence in the pharmaceutical and biotech sectors, one podcast episode at a time!
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Episodes (20/32)
The QP Diaries, by AssureBio
Earning the QP Title: Graham Clarke on Career Growth and Life as a QP Consultant

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.

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3 months ago
39 minutes 24 seconds

The QP Diaries, by AssureBio
From NHS QP to Innovation Leader – Adam Walker on Aseptic Transformation, AI & GMP Clarity

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.

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4 months ago
38 minutes 51 seconds

The QP Diaries, by AssureBio
The Long Road to QP: Lessons in Leadership and Learning

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.

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4 months ago
39 minutes 19 seconds

The QP Diaries, by AssureBio
The Making of a Modern QP: Damian Larrington on Quality, AI & Courage

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.

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5 months ago
38 minutes 28 seconds

The QP Diaries, by AssureBio
Mistakes, Milestones & Mastery: Marie’s Journey to QP Excellence

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.

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5 months ago
35 minutes 52 seconds

The QP Diaries, by AssureBio
Embracing Every Opportunity: Dave’s Journey to Becoming a QP

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.

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6 months ago
40 minutes 22 seconds

The QP Diaries, by AssureBio
Becoming a QP – Navigating Change, VIVA Prep & Real-World Insights with NSF Trainer Vicky

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.

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6 months ago
49 minutes 45 seconds

The QP Diaries, by AssureBio
Championing Quality, Leading with Purpose: Uche Ekwuozor on Diversity and Integrity in Pharma EP 13

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.

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7 months ago
42 minutes 57 seconds

The QP Diaries, by AssureBio
Investing in People and Culture ~ The QP Diaries ~ Catherine Kay ~ Episode 12

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.

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7 months ago
36 minutes 7 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 11 [Mark King]

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.

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11 months ago
13 minutes 11 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 10 [Ilona Stezowska]

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.

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1 year ago
13 minutes 15 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 9 [Rebecca Rutter]

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.

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1 year ago
12 minutes 31 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 8 [Phil Rose]

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.

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1 year ago
15 minutes 49 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 7 [Robin Railton]

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.

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1 year ago
15 minutes 28 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 6 [Kevin Currie]

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.

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1 year ago
13 minutes 41 seconds

The QP Diaries, by AssureBio
Inspiring and Empowering the Next Generation of QPs ~ The QP Diaries ~ Kevin Currie ~ Ep6

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

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1 year ago
49 minutes 1 second

The QP Diaries, by AssureBio
Bitesize Diary Entry - 5 [Richard Smalley]

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!

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1 year ago
14 minutes 44 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 4 [Adrian Zahra]

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.

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1 year ago
10 minutes 30 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 3 [Mukesh Patel]

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.

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1 year ago
7 minutes 4 seconds

The QP Diaries, by AssureBio
Bitesize Diary Entry - 2 [Chris Howell]

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/

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1 year ago
11 minutes 35 seconds

The QP Diaries, by AssureBio
The QP Diaries is brought to you by AssureBio. Our mission is to inspire and empower the next generation of QA professionals and future Quality Assurance leaders. If you're passionate about quality assurance and eager to learn from those in the industry, we'd be thrilled for you to subscribe and listen. 🌐 Website: www.assurebio.com 📧 Contact: dal@assurebio.com 📱 LinkedIn: https://www.linkedin.com/company/assurebio/ Let's together ensure quality assurance excellence in the pharmaceutical and biotech sectors, one podcast episode at a time!