API QC - QMS - Assistant Manager Fishfa Biogenics

6 - 10 years

5 - 12 Lacs

Rajkot

Work from Office

Job Summary: We are looking for a highly motivated and detail-oriented Assistant Manager Quality to join our quality team. The ideal candidate will be responsible for overseeing quality assurance (QA) and/or quality control (QC) activities to ensure compliance with regulatory standards (cGMP, WHO, FDA, etc.) and internal quality policies. This role is vital in maintaining product integrity and supporting continuous improvement initiatives. Key Responsibilities: Supervise and support QA/QC operations, including IPQA, documentation, and in-process checks. Ensure adherence to GMP guidelines and regulatory requirements in manufacturing and packaging. Review and approve quality-related documents such as SOPs, BMRs, BPRs, and change controls. Conduct and support internal audits, vendor audits, and regulatory inspections. Investigate deviations, out-of-specification (OOS) results, and non-conformities. Ensure timely CAPA implementation and monitoring. Manage sampling, testing, and release of raw materials, packaging materials, and finished products. Train and mentor junior QA/QC staff on SOPs, GMP, and safety standards. Coordinate with cross-functional departments including Production, R&D, and Regulatory Affairs.

Posted 1 month ago

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