The Committee
Click on the photos to see the person’s details
 Phil Butson |
 Ashley McCraight |
 Sam Clack |
 Peter Cormack |
 Norman Randall |
 Ian Birch |
 Allan Whiston |
 Jane Smith |
 Steve Moss |
 John Wilson |
Phil Butson
Chairman – Phil Butson
Phil is a pharmacist with a BPharm from the University of Bath and an MSc in Pharmaceutical Technology from King’s College, London.
Due to mergers, Phil is currently working for his third pharmaceutical company (GlaxoSmithKline), without ever having left the first one he joined (Wellcome)!
Phil spent 18 months in formulation development and then had 3 years supervising the packaging and labeling of clinical trial supplies before moving to his first QA role in 1993. He has experience of QA for both packaging and manufacture in both R&D and commercial environments. He is eligible as a Qualified Person under the permanent provisions of 2001/83/EC and MCQI CQP.
March 2007 – December 2010, he was the Quality Assurance Site Head for Pharmaceutical Development with GlaxoSmithKline Research & Development at Harlow and also responsible for Quality Assurance support to the GSK Phase 1 Clinical Unit at Addenbrookes Hospital, Cambridge. He now has a ‘Quality Futures’ role with a broad remit to ensure GSK R&D’s quality systems are proactively developed to meet future challenges.”
Phil joined PQG in 1998 and was elected to the committee in March 2001. He took over as Treasurer from Graham Davison in 2003 and held this position until 2010 when he took over as Chairman.
He has been actively involved in a number of PQG meetings and publications. In particular, he was the co-ordinating co-author for the revision of the PQG monograph on Pharmaceutical Auditing (2001) and co-editor of the monograph on Microbiological Control for Non-sterile Pharmaceuticals published jointly with Pharmig in 2008.
In addition to his activities for the PQG, he is a member of BARQA and has been a speaker at various professional meetings on the Quality Assurance of Investigational Medicinal Products, the Clinical Trials Directive (2001/20/EC) and Risk Management.
Phil became Chairman in April 2010
Ashley McCraight
Vice-Chairman – Ashley McCraight
Ashley obtained his first degree in Chemistry from Birmingham University following which he then joined Glaxo Laboratories where he occupied numerous roles in Quality Control at Greenford (London) and Barnard Castle.
Enticed into the Foods Division of the business as a development analyst, he returned to Greenford to work with the development team, based there and in Slough. During this time he studied part time for the Mastership in Chemical Analysis at Southbank University supplemented by practical experience at Public Analyst’s laboratories in London and Exeter.
After a period as Quality Control Manager in GlaxoFarley Food’s cereals and rusks factory in Plymouth, he moved to back into pharmaceuticals at Liverpool. A series of roles in most areas of QA, Manufacturing and Purchasing led to the role of Company QA Manager for Glaxo Pharmaceuticals which he held for five years.
A long term interest in the importance of suppliers to the industry, catalysed during his management of the Glaxo supplier development programme, led onto his involvement and eventual leadership of the ‘Partners’ project.
The ‘Partners’ Team has developed the supplier GMP application standards PS 9000 and PS 9100 for packaging and excipient materials and PS 9004, a guide to PS 9000.
Having left GlaxoWellcome in 1997 he has developed a business offering consultancy in Quality Management and in partnership with Andrew Coulter, a supplier evaluation service to the industry.
Ashley was Chairman of PQG from April 2007 to April 2010.
Secretary – Samantha (Sam) Clack
Samantha joined the Pharmaceutical Quality Group in 2002 where she was actively involved in organising and helping out with several Trainee QP meetings. In 2008, she was co-opted onto the committee to take over the organisation and administration of the Trainee QP activities.
She graduated from the University of Reading in 1993 with an Honours Degree in Microbiology and Biochemistry. She started her career with Patheon Ltd (formerly Hoechst Marion Roussel) in Swindon, where she worked in technical and managerial roles in manufacturing and packaging. Over the five year period that she spent with Patheon she gained experience in a wide range of dosage forms including sterile powder filling, sterile and non-sterile ointment filling, creams, liquids and suppository manufacture and filling, tabletting and packaging.
From 2000, Sam worked for Eli Lilly & Company Limited as a Senior Quality Assurance Associate within the Corporate Quality Assurance division based in Windlesham, Surrey. Her responsibilities included auditing Lilly’s Third Party Contractors and suppliers and providing training for Lilly affiliates worldwide. After four years she transferred to the Quality Operations Department at Lilly’s UK manufacturing facility based in Basingstoke where solid dosage forms were manufactured and packaged. Sam qualified as a QP in May 2005.
In 2008, she took on the role of QA Manager at Eisai in Hatfield in 2008 as was involved in the start up of a new solid dose manufactuirng facility.
In 2010, Sam started her own consultancy business and at the same time became the PQG Secretary.
Samantha has two Post Graduate Diplomas in Business Management and Industrial Pharmaceutical Studies and is an ISO Lead Auditor.
Peter Cormack
Treasurer – Peter Cormack
Peter is currently the Director of QA Compliance for the External Sourcing group at AstraZeneca. He was elected to the PQG Committee in 2009 and replaced Phil Butson as the treasurer when he moved to take the Chair of the group.
Peter is a Chemist and has spent over 25 years working in the Pharmaceutical industry in QC, QA and Technical Support roles. He has direct experience of sterile product manufacture (terminally sterilized and aseptically prepared), solid dosage formulations, and API Manufacture.
He spent time working overseas in Italy at the then Zeneca factory near to Milan as GMP Compliance Manager for the plant producing a terminally sterilized injectable anesthetic, before returning to the UK to embark on studying to become a QP.
Peter became an eligible QP in 2000, and until recently was named as QP on the AZ Manufacturing Authorisation for the Macclesfield manufacturing site.
Events co-ordinator- Jane Smith
Jane is currently the Events Coordinator for the group. She joined the PQG in 1991 as a member of the Supplier’s Partners Team.
Jane has worked in the Pharmaceutical industry for over 25 years. She joined Upjohn Ltd, Crawley in 1982 and held various technical and managerial roles in Quality Assurance where she gained experience in the manufacture and packaging of a wide range of dosage forms and also experience in sterile and dry products Clinical Trial manufacturing and packaging.
From 1991 until 1999, Jane was Site Quality Manager responsible for the Quality Assurance of Commercial and Clinical Trials manufacturing and packaging, Chemistry/Pharmacy regulatory submissions and the Chemistry, Microbiology and Environmental Control laboratories.
After leaving Upjohn, Jane took a 2 year break after which she joined Acumen Pharmaceutical Supplier Evaluation for 5 years as a consultant auditor conducting Supplier Audits to PS9000 and PS9100 in the UK, Europe and the U.S.
Jane joined GlaxoSmithKline, Crawley in 2006 with responsibility for providing quality coaching and support to routine commercial production, new product introductions, launches and product transfers. Jane is currently in the Compliance Improvement Group and has specific responsibility for the site QMS, GMP training, the CAPA process, Annual Product Summaries and the Quality Site Exit process.
Jane is a Chartered Chemist (MRSC), Chartered Scientist and a Pharmaceutical Lead Auditor.
Steve Moss
Leader of PS Series standards (Partners) Project – Steve Moss
Steve has had a long term interest in the importance of suppliers to the industry, catalysed during his management of the Glaxo supplier development programme, led onto his involvement and eventual leadership of the ‘Partners’ project.
He leads the ‘Partners’ Team that has developed the supplier GMP application standards PS 9000 and PS 9100 for packaging and excipient materials and PS 9004, a guide to PS 9000.
Over the past 14 years Steve has had several different QA roles with GSK companies auditing and providing support for contractors for new products, service contractors and material suppliers. He previously worked in the chemical industry in development, manufacturing and project management. His current role with GSK is to provide QA input to projects in the Strategy & Global Logistics function. Projects range from supply chain temperature compliance through to new software for artwork development and control or serialisation. Also lead author for related Quality Management System policies and processes.
Ian Birch
Committee Member – Ian Birch
Ian began his career at Glaxo Wellcome as a respiratory analyst following completion of his pharmacology degree. He then moved through several operational and auditing roles prior to moving across to GSK Research and Development division.
Ian continued to develop his research quality experience with GSK before taking on the role of quality manager at Roche. Prior to moving to his current role as Head of UK Quality at Arrow Generics, he gained some insight into European Quality by acting as project leader within Roche’s global technical division based in Germany and Switzerland.
Ian is eligible to act as a Qualified Person, is a lean sigma green belt and was previously registered as an IRCA auditor. He also looks after the Advocacy area of the PQG website and can be contacted on the PQG Advocacy e-mail
Allan Whiston
Committee Member – Allan Whiston
Chartered as both a Mechanical Engineer and Quality Professional, Allan has practiced in the pharmaceutical industry for some 40 years, the last five years as a Consultant to the industry and its suppliers. He held a number of roles in Engineering before moving to Quality Operations in the late 80’s. Moving to corporate life in late 90s he was latterly responsible for global Supplier Quality, the Quality System and Procedures and KPI reporting to the Board.
Not new to the PQG, Allan became a member of the Suppliers Partners’ Team in the early 90s and was a team member in the development of PS9000.
Since the turn of the century Allan has been a permanent member of IPEC Europe’s Good Distribution Practice Committee, some years acting as Chair.
Allan looks after the PQG Certified Supplier Scheme and Auditor registration and he can be reached on Certification@pqg.org.
Norman Randall
Webmaster – Norman Randall
Norman is a Chemist and studied at Brighton Polytechnic for his first degree and later obtained his PhD by part-time study. He has worked in the pharmaceutical industry all of his life, starting with Beecham Research Laboratories in the R&D and QA laboratories.
Subsequently, he moved to Berk Pharmaceuticals, Rorer Pharmaceuticals, and then in 1990 to Rhône-Poulenc Rorer UK as Director of Quality at the Dagenham manufacturing plant. From 1995 to June 2000, he worked in the RPR corporate quality group in Paris, as Director of Supplier Assurance. In this role he was responsible for co-ordinating world-wide quality audit and other activities for suppliers to RPR; this included monitoring the potential effects of BSE on products made and bought by RPR.
The merger of RPR and HMR to form Aventis Pharma in 1999 gave him the opportunity to return to the UK and in July 2000, he set up his own pharmaceutical consultancy business. He now works with pharmaceutical companies on QA systems, Supplier Assurance and auditing.
He served on the British Pharmacopoeia Commission until 2005 and was on two of the expert Committees
Norman has been a member of the PQG for many years. He served as Chairman from 2001 to 2004. He was one of the three PQG members who set up the York Training Course and acted as a course Supervisor for 5 years and a lecturer for 14 years. He has been an active contributor to monographs, the PS series standards and more recently, the new IPEC/PQG Excipients GMP Guide. He has a strong interest in working with Qualified Persons and their training and for the PQG, he runs the annual MHRA discussion meeting.
He now maintains the web site so if you find any broken links, errors, or have any suggestions for the site please e-mail him on Webmaster .
John Wilson
Membership Secretary – John Wilson
John began his career in the pharmaceutical industry in 1973, being employed as Microbiology Section Leader at Upjohn’s Crawley facility. During his ten years at Upjohn he moved from the laboratory to take up a QA appointment and at that time was named on the company’s product license, and under the transition arrangements subsequently became a Qualified Person.
From Upjohn he spent two years as QA manager for a contact lens solution manufacturer before moving into pharmaceutical consultancy with PED, a forerunner of Bovis Tanvec. Whilst having a consultancy role he established the validation department (mid 1980s) when GMP compliance and validation were becoming key issues for the pharmaceutical industry.
After eight years he moved into Engineering Contracting where he has specialised in GMP consultancy and validation activities for John Brown (now Kvaerner Process), Raytheon (now Washington Group International) and Jacobs Engineering.
Since 2007 he has been employed by Lonza Biologics plc where he is employed as a Qualified Person.
John is also a Chartered Microbiologist and has been a member of the PQG since the late 1980s. He became the PQG’s first Membership Secretary, a position created in response to the continued growth of the group, and continues in that role.
John can be reached on Membership@pqg.org and can help you with any issues related to your membership issues.