Manager - Analytical Method Validation

Key ResponsibilitiesEnsure compliance with cGMP, data integrity, and regulatory requirements.Manage Analytical Method Transfer (AMT), Validation (AMV), and Verification activities.Review and approve AMT/AMV protocols, reports, and related documentation.Ensure timely completion of validation, verification, and transfer projects.Review and approve analytical reports, records, and laboratory documents.Monitor daily laboratory activities and prepare periodic status reports.Coordinate with R&D, external laboratories, and customers for smooth project execution.Oversee testing at external laboratories where in-house facilities are unavailable.Lead investigations related to OOS, OOT, OOE, deviations, change controls, and CAPA.Coordinate with QA, RA, Production, EHS, and other cross-functional teams.Conduct GMP and technical training programs for laboratory personnel.Develop and mentor Officers, Executives, and Chemists.Ensure audit readiness and continuous compliance within the laboratory. QualificationM.Sc. (Chemistry/Analytical Chemistry) or equivalent. Experience10-15 years of experience in Analytical Method Validation (AMV), Method Transfer (AMT), Method Verification, and Quality Control in a regulated pharmaceutical environment.

Key SkillsAMV, AMT, Method Verification, cGMP, Regulatory Compliance, OOS/OOT Investigations, CAPA, Data Integrity, Team Leadership, and Project Management.