Job Description

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...

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