Katalyst Healthcares & Life Sciences
AIQ (Analytical Instrument Qualification) SME
Katalyst Healthcares & Life Sciences, Skaneateles Falls, New York, us, 13153
Technical Sme For Analytical Equipment Qualification
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 and compliance with regulatory standards.
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 and compliance with regulatory standards.