People
Keith Williams
Chief Executive Officer
Keith founded GxPi in 2000. Keith brings over 20 years of Biopharmaceutical experience, particularly in computer systems validation. He has worked in a manufacturing, laboratory and clinical environment extensively in Europe and the US. He has been actively involved in initiatives in the Drug Information Association (DIA), Parenteral Drug Association (PDA), ISPE and IChemE Pharma group over many years.
He has a BSc in Genetics and Microbiology and an MSc in Biochemical Engineering.
Mark Stevens
Operations Director
Mark has been responsible for the successful delivery of projects within the Biopharmaceutical industries in a variety of business areas since GxPi was founded in 2000. During this time he has been involved with engineering design, project management, commissioning, validation, and strategic planning and consultancy. Mark has managed to successful completion over 40 projects in the EMEA and US regulatory environment, across Biotech, Pharmaceuticals and Nutraceuticals. These projects have been scrutinised by both European and US based auditors.
Jonathan Burd
Solutions Director
A pharmacist by background, Jonathan has 30 years experience working in healthcare and life sciences. After working for 15 years in the NHS, Jonathan moved into consultancy and software development where he has undertaken a wide variety of roles. For the last 10 years, prior to joining GxPi, Jonathan has been involved in providing enterprise content management solutions into the Life Sciences market on industry leading products based on the Documentum and SharePoint platforms. He brings this experience to GxPi to provide further domain input to the x-docs™ product development as well as consulting and subject matter expert support to project implementations.
Phil Harrison
Consultant, Product Quality Manager
Phil is a chemist by background, now a specialist in Quality Management Systems and in the validation and compliance of Information Systems used in the Pharmaceutical Industry. He has more than 20 years experience in large organisations operating in a GxP environment, covering active ingredient manufacturing (GMP), and Research and Development. Phil is a consultant supporting clients in compliance, QMS, auditing and validation projects. He is also the Product Quality Manager for GxPi's x-docs™ product range.
Dr Anthony Gasson
QP and Regulatory Consultant
Tony is qualified and experienced both as a Microbiologist and an Analytical Chemist. He has acted as a Qualified Person since its inception in the 1970's, releasing products for world markets under BP, EP, and FDA or WHO requirements. Tony qualified in Physiology with Chemistry, and joined the Wellcome Research Laboratories as a Research Scientist working on Diagnostics. He became a Senior Scientist involved in development, production and control of vaccines for medical and veterinary use. Later he managed Microbiological Laboratories controlling all Wellcome Products worldwide.
He joined the Public Health Laboratory Service in 1989 as Director/Head of Quality Assurance and Regulatory Affairs. He introduced Quality Standards to the Headquarters at Colindale and the Centre for Applied Microbiology and Research, Porton Down, obtaining new licences for vaccine products in the UK and USA. Since 1995 he has worked as a Principle Consultant, advising on Regulatory Compliance and Pharmaceutical Engineering for the design, construction and validation of new facilities for the Pharmaceutical and Biotechnology Industries. He has trained staff in a large number of countries.
Jim Stracey
Manufacturing and Strategic Pharmaceutical Consultant
Jim has a wide experience gained over 40 years within the pharmaceutical industry, covering production/general management within the manufacturing sector, plant engineering and project engineering and management. Recent experience includes pharmaceutical development and clinical trials supply facilities, high-containment facilities, and multi-purpose API production and pilot plants for major pharmaceutical companies. He has specialist knowledge and experience in high-potency materials operations and the industrialization of new products.
During an industrial career with GSK/Beecham Pharmaceuticals, he became site director of the Crawley facility after working in primary plant engineering and production management followed by secondary production management. Subsequently Jim spent a period overseas in Europe and the US in pharmaceutical project planning, design and management. From 1993 to 2006, he worked with AMEC Group as a Pharmaceutical Consultant working on a range of projects including product development, clinical trial manufacture and commercial scale up.
Dr Tom Dine
Regulatory and Validation Consultant
Tom has been involved with regulatory compliance, validation, project management, product development and QC analysis of pharmaceutical, biopharmaceutical and cosmetic manufacturing operations for over 25 years. He has worked with many of the world's leading pharmaceutical and biopharmaceutical manufacturers. Tom has worked across a broad range of business areas incorporating research, development, pilot plant and commercial manufacturing facilities.