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 Chemists.
- Ensure audit readiness and continuous compliance within the laboratory.
Qualification
M.Sc. (Chemistry/Analytical Chemistry) or equivalent.
Experience
10–15 years of experience in Analytical Method Validation (AMV), Method Transfer (AMT), Method Verification, and Quality Control in a regulated pharmaceutical environment.
Key Skills
AMV, AMT, Method Verification, cGMP, Regulatory Compliance, OOS/OOT Investigations, CAPA, Data Integrity, Team Leadership, and Project Management.
