Rob Stephenson, PhD was previously Leader of the Pfizer Global Manufacturing Sandwich UK Regulatory Systems IT Team until the cessation of manufacturing at the site at the end of 2009 and is now working as an independent consultant. He has worked in various roles within the pharmaceutical and personal product sectors for companies such as The Boots Company, Eli Lilly, Unilever and Coty. Rob joined Pfizer in 2000 as member of their Quality Unit operating within the IT group where his responsibilities included coordinating the manufacturing site’s initiative to achieve 21 CFR Part 11 compliance and authoring their IT Quality Management System. He has had extensive experience with the implementation and operational control of a wide range of applications. As a long-standing member of the GAMP Europe Steering Committee Rob contributed material to GAMP®5 and the ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems, for which he was co-leader.
More recently Rob has also contributed material to the ISPE GAMP RDI Data Integrity: Key Concepts, and Data Integrity by Design Good Practice Guides.