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.

Skills Required

Hplc, Usfda, Uv, Dissolution, Cgmp, Ir, Glp, Gc