12 episodes

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!

The QP Diaries, by AssureBio Dal Pawar

    • Science

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!

    Strategies for a successful VIVA, from a former QP Assessor's Perspective ~ Ep11

    Strategies for a successful VIVA, from a former QP Assessor's Perspective ~ Ep11

    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.

    • 45 min
    Artificial Intelligence in a GxP environment and its impact on YOU. How to stay relevant in the AI world

    Artificial Intelligence in a GxP environment and its impact on YOU. How to stay relevant in the AI world

    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.

    • 21 min
    Navigating the Journey to Becoming a Qualified Person ~ The QP Diaries ~ Ilona Stezowska ~ Ep10

    Navigating the Journey to Becoming a Qualified Person ~ The QP Diaries ~ Ilona Stezowska ~ Ep10

    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.

    • 38 min
    Innovative strategies for leadership that develop robust quality teams and advice for broadening your QP network ~ The QP Diaries ~ Rebecca Rutter ~ Ep9

    Innovative strategies for leadership that develop robust quality teams and advice for broadening your QP network ~ The QP Diaries ~ Rebecca Rutter ~ Ep9

    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.

    • 52 min
    Failing the VIVA first time- how to stay on track, stay motivated and achieve your goals ~ The QP Diaries ~ Phil Rose ~ Ep8

    Failing the VIVA first time- how to stay on track, stay motivated and achieve your goals ~ The QP Diaries ~ Phil Rose ~ Ep8

    ..
    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.

    • 33 min
    Demystifying remediation challenges as a QP and employing strategies for success ~ The QP Diaries ~ Robin Railton ~ Ep7

    Demystifying remediation challenges as a QP and employing strategies for success ~ The QP Diaries ~ Robin Railton ~ Ep7

    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.

    • 49 min

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