Found Description
Location: Limerick, Ireland
Job Type: Full-Time
Experience: 10+ Years
Role Overview
We are seeking an experienced Senior CSV Lead to manage validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires strong expertise in Computer System Validation (CSV), Software Validation, IQ/OQ/PQ execution, Data Integrity, and regulatory compliance.
The successful candidate will lead validation lifecycle activities for manufacturing, laboratory, automation, and enterprise systems while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
Key Responsibilities
• Lead end-to-end CSV lifecycle activities for GxP systems.
• Develop and execute IQ/OQ/PQ protocols and validation documentation.
• Review and approve URS, Risk Assessments, Traceability Matrices, and Validation Summary Repo...
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