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Dave Waddington (Secretary)
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.
Jenny is a Chemist, having graduated from the University of Manchester with a BSc (Hons) in Chemistry. She first worked as a QC Chemist at Bio Products Laboratory from 1998 to 2001. She then moved to the Novartis, Horsham site until 2006. She worked in Quality, initially performing batch record reviews and moving on to having responsibilities for all the Quality aspects for a defined set of products and processes on site. She also spent a period of time as a Productivity Manager, responsible for manufacturing and packaging processes within a Process Unit. Jenny spent a year working for Phoqus Pharmaceuticals and gained experience here with IMP and GMP interfaces with GCP. In 2008, Jenny joined Astellas, in a EMEA regional role and working as part of a global QA team. She has worked on regional and global Quality System implementation and improvement projects, working with global counterparts and EMEA Manufacturing sites and Affiliates. Her current role is in Quality Technology, where she supports commercial readiness activities for new products.
Jenny has a Diploma in Quality Assurance and Management, awarded by the IQA in 2006 (now known as the CQI), and in 2015 she gained eligibility to act as a Qualified Person under the permanent provisions.
Within the PQG Committee, Jenny is the Monographs Co-ordinator and is responsible for a program of update of the current Monographs and identifying areas for new Monographs. If you are interested in finding out more or contributing in this area, Jenny can be contacted via email@example.com
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 was 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 served as Chairman from April 2010 – March 2013 and is now the Webmaster. If you find any broken links, errors, or have any suggestions for the site please e-mail him on Webmaster@pqg.org.
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. He is currently acting as monographs co-ordinator and is actively involved in the creation of the joint PQG/ECA Academy GDP guidance.
In addition to his activities for the PQG, he is a member of RQA 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.
Stephan graduated from the University of Luton, now University of Bedfordshire, in 2003 with a First Class BSc Biology with Honors. Stephan joined the PQG in 2008 as a member and as of 2013, has assumed responsibility for coordinating and presenting at trainee QP events.
From 2004 to 2007, Stephan initially worked as a Microbiologist and then QA Officer for Cobra Biomanufacturing, where he was involved with the initial and ongoing implementation of cGMP QC practices, validation, environmental monitoring, maintenance of QA administered systems and Biologic API and product batch disposition.
In 2007 Stephan joined Allergan, where he has worked to date within a clinical trials supply secondary packaging distribution facility which functions to support global clinical trials. During this time, Stephan has progressed his career from Senior QA officer to Quality Manager and QP.
His current role is as Quality Manager, Qualified Person and Quality Controller for investigational products manufactured within Allergan Marlow for global distribution. Dosage forms include both Sterile Biologic and non biologic injectables, ophthalmic preparations, suspensions and capsules.
Stephan current responsibilities include management of the QA team, batch disposition and strategic direction in developing, implementing and maintaining appropriate, effective local and Global Quality systems which support the Global clinical supply chain.
Having graduated from the University of Bedfordshire in 2004, Damian started a career in Secure Supply Chain. He developed a broad understanding of inventory management systems, SOPs and auditing to ISO9001 standards.
In 2012 Damian was keen to change direction back to a scientific role and entered the Pharmaceutical industry with a positon in Allergan’s Global Pharmaceutical Development Compliance team supporting the supply and compliance of Global Clinical Trials using developmental ophthalmic solutions and biologics. Damian developed a talent for delivering interactive training sessions; he also took the lead for global quality management review. Damian gained exposure to multiple quality systems and during his time at Allergan Damian began his QP training; he has completed all of his QP modules with NSF (formerly DBA).
In conjunction to his QP training in 2016 Damian completed an MSc in Pharmaceutical Quality & GMP with the University of Strathclyde. Damian has completed the IRCA accredited NSF effective lead auditor course and is a member of the Royal Society of Biology.
Damian is a Senior Manager for Pfizer in the Global Supply Chain Quality Operations department based in Hurley (UK). He is responsible for ensuring timely review and QP certification for batches of Sterile injectable products into the EMEA region and ensuring ongoing compliance of the UK site with EU GMP.
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Ian holds a PhD in Chemistry and an MBA in Business Administration. He has a long-term interest in the importance of GMP to Pharmaceutical Excipients, as well as the value of GMP in the food and personal care industries.
Ian joined the PQG Committee in 2015 assuming the role of Excipients Standards Coordinator, with the objective to ensure that the PQG contributes to the development of standards for Excipient GMP / GDP on a global basis. Ian is an active member of the EXCiPACT team aligning the EXCiPACT standards to the new ISO standards.
Ian is global Technical Marketing Manager for PQ Silicas, with responsibility for identifying new growth opportunities, together with ensuring the company’s global manufacturing standards and quality meets regulatory requirements in the pharmaceutical, food and personal care markets.
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 with the PQG ‘Partners’ project.
With the ‘Partners’ Team he has helped develop the supplier GMP application standards PS 9000 and PS 9100 for packaging and excipient materials and PS 9004, a guide to PS 9000. He has also been heavily involved with joint steering committees with IPEC and IPAC-RS and also the development of the EXCiPACT project for PQG. With leadership of the ‘Partners’ Team he joined the PQG committee. He was elected as Vice Chair in 2012 and transitioned to the Chair in 2013.
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 Quality Operations Manager covering a range of contractors in Europe.
Steve can be contacted on Chairman@pqg.org.
Jayne is a Graduate of the Royal Society of Chemistry who has worked within the pharmaceutical industry in quality roles at Bristol-Myers Squibb (BMS) for 25 years.
Jayne has experience in the Quality Assurance and Quality Control functions within the Investigational Medicinal Products division of BMS. Her current role is within the Global Auditing group where she is a manager and auditor with responsibilities for the Global Vendor Assurance Programme and Internal BMS facilities audits. Jayne is also a Qualified Person for IMPs.
Jayne has been an active member of the Rx-360 and EXCiPACT™ teams which developed the standards for Auditor Qualification and Competency.
Within the PQG Committee, Jayne is responsible for the Supplier Certification Programme, having taken on the role in September 2013. Additionally she will be taking on the role as the PQG representative on the EXCiPACT™ General Assembly in 2015.
Jane Smith – Membership Secretary
Jane is currently the Membership Secretary 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 30 years. She joined the Upjohn Ltd Crawley site in 1982 and held various technical and managerial roles in Quality Assurance, including Site Quality Director, where she gained experience of the manufacture and packaging of a wide range of dosage forms and also experience in sterile and dry products Clinical Trial manufacturing and packaging.
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 in 2006 in the Operational Quality Group responsible for day to day quality management of the Dry Products Packaging area and Topical Preparations manufacturing & packaging areas. She then moved to the External Supply group where she was responsible for providing quality coaching and support to routine commercial production, new product introductions, launches and product transfers for several Contract Manufacturing Organisations across Europe. Jane is currently in the Quality Systems Improvement Group, responsible for the GSK Global Risk Models.
Jane is a Chartered Chemist (MRSC), Chartered Scientist and a Pharmaceutical Lead Auditor.
Jane can be reached on Membership@pqg.org and can help you with any issues related to your membership.
Dave is a Chemist with a degree from Loughborough University and is eligible to be nominated as a Qualified Person (permanent provisions). His career in various Quality roles within the pharmaceutical industry now spans more than 30 Years, during which time he has benefited from working with many different types of dosage forms for global supply.
Dave joined GlaxoSmithKline (Beecham Pharmaceuticals) in 1986 as an analytical development scientist working on method development and validation. From there he progressed into management taking responsibility initially for the analytical development team and then moved onto manage the sites regulatory compliance function.
In 1997 Dave joined Seven Seas Limited in Hull as Quality Manager and acted as the sites main certifying QP. This role provided a great insight into requirements for natural products, such as fish oils, herbals, homeopathic products and fast moving consumer goods.
In 2007 Dave took on the role of site Quality Director for Catalent at their packaging facility in Corby. The role required good knowledge and control of supply chains and customer relationship management.
Dave’s current role with Catalent is Quality Director, Global Regulatory Compliance. A forward looking role with responsibility for monitoring and reacting to changes in regulations and requirements impacting Medicines, Food Supplements, Cosmetics and Medical Devices for markets globally. Dave also participates in the Catalent internal audit programme and provides compliance advice and support to their EU QP network, Quality teams and QMS development.
Neil is a Microbiologist with a degree from the University of Strathclyde and is eligible to be nominated as a Qualified Person (permanent provisions).
Neil joined the Pharmaceutical Quality Group in 2009 and has been actively involved in running the annual MHRA/PQG meeting for the last 4 years. In 2013 Neil was voted on to the PQG committee as Treasurer.
Following brief spells at Roche and then ICI Nobel’s Explosives, Neil joined Zeneca Pharmaceuticals (formerly ICI and now AstraZeneca) in 1987 initially as a Process Development Chemist working on the scale up of range of new chemical entities at their Macclesfield site in the UK.
In 1990 he moved to the Quality Assurance function where he was initially responsible for Environmental Monitoring (Personal and Environmental).
In 1992 he set up a new Stability Testing Group responsible for all UK manufacture product stability covering ongoing maintenance studies and studies in support of line extensions and process changes. He played a key role in the development of Zeneca Pharmaceuticals worldwide stability policy post ICH Q1A and in the development of new systems and structures to support international annual maintenance stability programmes within Zeneca.
In 1997 he moved in to a QA role to support New Product Introduction for a new sterile formulation facility covering all aspects of QA support from design through to construction, validation and finally PAI.
In 2001 he transferred to AstraZeneca’s API facility near Bristol as a QA manager and during this time started to support external supplier management and finally completed his QP.
In 2006 he joined Global External Sourcing working initially with global API contractors before moving to Regional External Supply (EMEA) as a Senior QA Executive where he managed all local contractors covering API and Formulated products for the region as well as setting up aligned QA for a new EMEA regional distribution organisation.
Neil is currently a QA Group manager, QP and RP on the license at AstraZeneca’s second largest manufacturing site at Macclesfield in Cheshire and is primarily responsible for the site QMS.
PQG Committee, December 2014: (L to R) Sam Clack, Stephan Croft, Neil Wayman, Phil Butson, Steve Moss, Norman Randall, Jayne Nicholas