Act as the delivery organization spoc for all GxP requirements for a given scope
Operational implementation and of the Atos GxP Policy in full alignment to a given scope
Understanding and translating all customer and regulatory requirements into day-to-day operational tasks and activities
Act as the GxP subject matter expert in the IT Domain – a techno-functional GxP requirements manager in operations
Identify, track and continually improve metrics relevant to GxP to enhance operational GxP performance
Implement and continually track all GxP-relevant controls as part of the Atos IT Control Framework
Drive and manage core operational compliance areas such as infrastructure qualification, application validation, manual testing
Drive and manage all GxP training and knowledge related requirements for the operational staff within the GxP Scope
Collaborate and work close with global GxP requirements owner and other relevant process owners to implement and strengthen the Atos GxP Baseline
Work together with ITSM process and function leads relevant to GxP on sustaining and continually improving the Atos GxP Baseline
Assist in bringing automation and transformation in regulated GxP environments from a technical perspective
Experience:
Years of experience in providing IT support and enabling IT infrastructure for regulated environments related to 21 CRF (Code of Federal regulations) part 11 assessments, 21 Part 801, Annexure-II etc.
Operational experience of hands-on work on regulated systems and applications
End to End Validation planning and Project execution for IT systems in GxP (e.g. GPvP, GMP, GLP)
Considerable experience in application/systems/software validation and infrastructure qualification procedures for regulated environment