Assistant Manager - Quality Control

Job Description: Oversee and manage QC activities for finished dosage formulations, raw materials, in-process, and stability samples. Ensure compliance with cGMP, GLP, and regulatory guidelines (USFDA, EUGMP, etc.) in all QC operations. Supervise and guide the QC team in chemical, instrumental (HPLC, GC, UV, Dissolution, IR, etc.), and microbiological testing. Review and approve analytical reports, specifications, SOPs, and COAs. Coordinate with QA, Production, and R&D departments to ensure timely release of materials and products. Handle OOS/OOT investigations, deviations, CAPA, and ensure root cause analysis with effective implementation. Monitor stability studies and prepare data for regulatory submissions. Ensure calibration, qualification, and maintenance of laboratory instruments. Conduct training for QC staff to enhance skills and compliance culture. Support audits (regulatory and customer) and ensure timely closure of observations.

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