Manager - Analytical Method Validation

Key Responsibilities\nEnsure compliance with cGMP, data integrity, and regulatory requirements.\nManage Analytical Method Transfer (AMT), Validation (AMV), and Verification activities.\nReview and approve AMT/AMV protocols, reports, and related documentation.\nEnsure timely completion of validation, verification, and transfer projects.\nReview and approve analytical reports, records, and laboratory documents.\nMonitor daily laboratory activities and prepare periodic status reports.\nCoordinate with R&D, external laboratories, and customers for smooth project execution.\nOversee testing at external laboratories where in-house facilities are unavailable.\nLead investigations related to OOS, OOT, OOE, deviations, change controls, and CAPA.\nCoordinate with QA, RA, Production, EHS, and other cross-functional teams.\nConduct GMP and technical training programs for laboratory personnel.\nDevelop and mentor Officers, Executives, and Chemists.\nEnsure audit readiness and continuous compliance within the laboratory.\n\nQualification\nM.Sc. (Chemistry/Analytical Chemistry) or equivalent.\n\nExperience\n10–15 years of experience in Analytical Method Validation (AMV), Method Transfer (AMT), Method Verification, and Quality Control in a regulated pharmaceutical environment.\n\nKey Skills\nAMV, AMT, Method Verification, cGMP, Regulatory Compliance, OOS/OOT Investigations, CAPA, Data Integrity, Team Leadership, and Project Management.