Assistant Manager / Manager (Quality Control) Spectrum Talent Management

12.0 - 17.0 years

11 - 17 Lacs

Ahmedabad

Work from Office

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

Posted 1 month ago

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