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.
- Develop and mentor Officers, Executives, and Chemis...