People
We have a very experienced staff and a network of over 40 specialists in the UK, Europe and the US. Listed below are those key individuals based out of the UK HQ:
Keith Williams
Chief Executive Officer and Principal Consultant
Keith founded GxPi in 1999 and brings over 20 years of Life Sciences experience, particularly in a pragmatic approach to computer systems validation. He has worked in a manufacturing, laboratory and clinical environment extensively in Europe and the US. He has a BSc in Genetics and Microbiology and an MSc in Biochemical Engineering.
Mark Stevens
Operations Director and Principal Consultant
Mark has been responsible for the successful delivery of projects within the Life Sciences sector in a variety of business areas since GxPi was founded in 1999. He has 20 years of experience with delivering projects that have utilised a risk based approach to limit the cost of compliance and have been scrutinised by both European and US based auditors. Mark has BEng in Chemical Engineering with Biochemical Engineering.
Jonathan Burd
Product Director and Principal Consultant
A pharmacist by background, Jonathan has 30 years’ experience working in Healthcare and Life Sciences. After 15 years in the NHS, Jonathan moved into consultancy and software development where he has undertaken a wide variety of roles. He 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.
Phil Harrison
Product Quality Assurance Manager and Principal Consultant
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 helped many companies design their QMS tailored to their own specific regulatory framework, and has been responsible for developing practical methods for computerised system validation and for qualification of Cloud environments in the Life Sciences sector.
Jon Poyzer
Product Technical Manager
Jon is an Electronic Engineering graduate with over 10 years technical and management experience working with Information Technology and Software Development projects. He has an MCTS in SharePoint Configuration and manages the product output from the software development team and the technical delivery teams.
He has a broad technical knowledge particularly around infrastructure, virtualisation, automated scripting and hosting environments and has worked on projects in Europe and the US.
Krunal Desai
Senior Product Developer
Krunal is a Computer Science graduate with 10 years deep Software Development experience, first at Experian and then GxPi. He has an MCTS in SharePoint Development and he architects, designs and codes our product. He built x-docs™ 1.4, and 2.0, x-train™ 1.2 and is leading the conversion and design of our other products onto SP 2010 (2.0) Foundation platform.
Stephen Long
Product Quality and Senior Consultant
Stephen is a pharmaceutical Scientist by training with considerable GxP experience. Stephen is a specialist in GxP computer systems validation and has implemented, configured, validated and managed computerised systems which are compliant to relevant regulatory requirements (for example 21 CFR part 11).
Stephen manages the documents in our Quality Management System (QMS) and is responsible for the product validation testing. Stephen is an effective consultant and trainer, supporting clients in compliance and validation projects. He has a strong background in analytical instrumentation (in particular HPLC) including method development and validation (ICH guidelines). Stephen has completed successful analytical method transfers to clinical research organisations in both Europe and the US.
Dr Anthony Gasson
QP and Regulatory Principal 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, FDA and WHO requirements. 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 Principal Consultant, advising on Regulatory Compliance and Pharmaceutical Engineering for the design, construction and validation of new facilities for the Pharmaceutical and Biotechnology Industries.
Jim Stracey
Manufacturing Principal Consultant
Jim has a wide experience gained over 40 years within the pharmaceutical industry, covering site leadership, production, plant engineering, engineering and project management. Recent experience includes pharmaceutical development and clinical trials supply facilities, high-containment facilities, multi-purpose API production and pilot plants. He has specialist knowledge and experience in high-potency materials operations and the industrialisation of new products.
Dr Tom Dine
Regulatory and Validation Principal 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 qualified as a chemist and has worked across a broad range of business areas incorporating research, development, pilot plant and commercial manufacturing facilities.
