Manager – Analytical Method Validation

Key Responsibilities

• Ensure 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.
• Dev...