Rob Stephenson joined the Boots Company in 1977 in their Technical Service Group and since then has worked in various roles within the pharmaceutical and personal product sectors for companies such as Eli Lilly, Unilever and Coty. He joined Pfizer in 2000 as member of their Quality Unit operating within the IT group, where his responsibilities included co-ordinating the manufacturing site’s initiative to achieve 21 CFR Part 11 compliance and authoring their IT Quality Management System - based on GAMP principles.He has had experience with the implementation and operational control of a wide range of applications including Document Management Systems (EDMS), Laboratory Systems (CDMS and LIMS) and CAPA/Change Management systems. He was a long-standing member of the GAMP Europe Steering Committee (2001 - 2014) and has contributed material to GAMP®5 and the GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerised Systems - for which he was co-leader. More recently Rob has also contributed material to the ISPE GAMP RDI Data Integrity Good Practice Guides: Key Concepts, and Data Integrity by Design . Recent experience includes various assignments related to Computerised Systems Validation and Data Integrity (audits and training).Specialties: Computer Systems ValidationRegulated IT System Implementation and OperationContinuous ImprovementChange ManagementData Integrity Audit & Training
Listed skills include Gamp, Computer System Validation, Continuous Improvement, Change Management, and 21 others.
