AIQ (Analytical Instrument Qualification)

Key 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, Validation, Metrology, IT, and Lab teams to define qualification strategies for new and upgraded equipment. Maintain traceability between user requirements, functional specifications, and qualification deliverables. Provide guidance on change control and impact assessments for equipment modifications or upgrades. Support audits and inspections by presenting qualification documentation and providing SME-level responses. Drive continuous improvement in qualification practices and documentation templates across global sites.