QC Assistant Manager Emil Pharmaceutical

8.0 - 12.0 years

8 - 10 Lacs

Boisar

Work from Office

Role & responsibilities 1. Quality Control Operations Supervise and perform analysis of in-process and finished pharmaceutical products as per pharmacopeial methods (IP, BP, USP, EP). Ensure timely sampling and testing of batches during manufacturing and post-production. Monitor compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) . Conduct HPLC, GC, UV, IR, KF, Dissolution, and other instrumental testing . Maintain and calibrate laboratory equipment. 2. Documentation & Review Review and approve analytical reports, CoAs, and logbooks. Ensure proper documentation of results in LIMS or paper-based systems as per ALCOA+ principles. Investigate OOS, OOT, and deviations related to finished products and in-process samples. 3. Compliance & Regulatory Support regulatory inspections (USFDA, MHRA, WHO, etc.) and customer audits. Maintain readiness of QC labs as per regulatory requirements. Participate in internal and external audits and implement CAPAs. 4. Team Management & Training Supervise QC analysts and ensure task allocation and training. Develop SOPs, and provide on-the-job training to the QC team. Coordinate with QA, Production, and Warehouse teams for smooth QC operations.

Posted 1 month ago

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