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David has been affiliated with the Pharmaceutical Quality Group for more than thirteen years and during this time has been actively contributing towards the development of Standards and guidance publications for the Pharmaceutical packaging supply chain, which have included PS9004, ISO 15378, EN15823 Braille on packaging for medical products and the 2001 edition of PS 9000.
Following project managing the development of the new updated PS 9000:2011 interactive document, he now chairs the PQG partner’s team as well as continuing with his interests on the BSi global platform and the packaging society.
David has extensive experience in business and Quality Management systems. His background has seen him working both with and within the print and packaging sector, supply chain and a number of pharmaceutical and packaging businesses over his career developing and implementing both quality management systems and the application of pharmaceutical Good Manufacturing Practices. During this time, he worked for M.Y Healthcare; as the QA Manager of the Portsmouth site (Kohler Packaging) and went on to take up the role of Divisional Quality Manager for all UK & Ireland sites.
David currently continues to work with a number of industry sector businesses providing guidance and support in the deliverance and application of various management systems and process interfaces as well as designing and delivering new training packages.
Sacha’s background is exclusively Pharmaceutical and Healthcare having worked within the Supplier Quality Arena for GSK for nearly 15 years.She has experience of the majority of components from primary pack through to tertiary, as well as API and excipients, and has worked with the majority of dose forms and devices.
Sacha was part of the PS900:2011 working party where she relished the opportunity to get involved with suppliers and customers alike making real ‘forward thinking’ updates such as change control with a risk approach and a shift in focus for gang printing evaluation.
Donna is a Chartered Chemist and Chartered Scientist with a degree in Applied Chemistry and a Postgraduate Diploma in Pharmaceutical Industrial Science. Donna has worked in the pharmaceutical industry for nearly 30 years with 18 years spent with GSK at manufacturing sites and lastly with the clinical trial manufacturing group in GSK R&D. During her time at GSK, Donna worked in stability and method development labs, process technology, GMP auditing, in-coming materials QA, supplier management QA, production QA and clinical trial QA, gaining her Qualified Person (QP) status in 2001. Since leaving GSK in 2005, Donna has worked as a QP in the generic pharmaceutical industry and also as a contract auditor of API facilities. Donna is currently working as a consultant QP & Auditor with her own consultancy.
Esme’s background is Pharmaceutical manufacture and packaging ranging from sterile products, tableting, API, clinical trials and OTC medicines. Esme has always worked in either QC or QA and was a transitional QP for clinical trials. She has over 30 years of experience in the Pharmaceutical industry and presently work for The Mentholatum Company in Scotland as the Quality Manager.
In addition to medicines, she also has experience with medical devices and qualified as a supplier Lead Auditor.
Esme was was part of the PS900:2011 working party which was a challenge in addition to her day to day job but very rewarding when the standard was published.
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Following a career of over 30 years in the pharmaceutical industry, Tony now provides auditing, consultancy, training and certification services for the Pharmaceutical and Medical Device Industries and their suppliers as well as carrying out notified Body CE Medical Device audits.
Tony was instrumental in setting up the Institute of Quality Assurance (IQA), Pharmaceutical Quality Group (PQG) in 1977 and was its Chairman for 15 years. Since then he has continued to be involved both as a Committee Member and member of the Partners Team.
In addition, Tony lectures on Quality Management at the Brighton University QP Post-Graduate Diploma course and continues to work with the International Standards Organization together with CEN and BSI drafting and contributing to business standards for the industry.
Jill is an accomplished Quality Management professional with over 20 years experience in Quality Management Systems across a number of industry sectors including pharmaceutical, medical devices, life sciences / biotechnology.
She has been a member of the partners team for a number of years. During this time she has been involved with a number of projects including PS 9000, PS 9004 and contributed to PS 9100.
Notably, Jill was the Project Lead for the Supply Chain Risk Management Guide which was a great opportunity, working with a team of enthusiastic and experienced people as well as wider industry experts.
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Ian McKeown – Partners’ Team Member
Ian joined the Partners Team from his involvement in EXCiPACT, the organisation set up to define Excipient GMP and auditor standards for IPEC. Ian is a chemist by training and currently Global Technical Manager for PQ Silicas.
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