Senior Executive-QC

Job Overview

To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing.

• Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products.
• Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH guidelines.
• Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities.
• Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments.
• Ensure timely qualification/calibration of instruments used in AMV lab.
• Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc.
• Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT.
• Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA.
• Maintain GLP and cGMP compliance across AMV operations.

Experience:

4 -5 years in QC-AMV in a regulated pharmaceutical environment