Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 requirements. Lead and support equipment lifecycle activities, including requalification, decommissioning, and periodic review. Ensure data integrity compliance in computerized systems interfaced with analytical instruments. Collaborate with Quality, Validatio…