Job Summary
In this role, you will be responsible for handling various computer system validation activities for different cross functional programs across West Pharma.
Essential Duties and Responsibilities
With guidance lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA). Perform system impact assessments and risk assessments to define appropriate validation scope and strategy. Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR). Demonstrate strong understanding of computerized systems, their intended use, data flows, and system lifecycle to ensure appropriate validation controls are established. Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementa...