Senior Manager Quality Control Microbiology

7 hours ago

pimprichinchwad, India Enzene Biosciences Ltd Full time

Manager / Lead – Microbiology (Sterile Pharma) Location: Chakan , Pune Industry: Pharmaceuticals (Sterile / Injectables)About the RoleWe're looking for a passionate and experienced Microbiology Leader to oversee and strengthen sterile microbiology operations. The role focuses on risk management, compliance, and team leadership in a high-quality, regulated pharmaceutical environment.Key Responsibilities- Risk Control: Identify, assess, and manage microbiological risks across raw materials, utilities, processes, and finished products.- Laboratory Operations: Lead day-to-day microbiology lab activities—testing, method validation, equipment and cleaning validation, EMPQ, microbial identification, and trending.- Problem Solving: Investigate and resolve OOS results, deviations, and environmental monitoring non-conformances. Drive CAPA implementation.- Team Leadership: Supervise, mentor, and develop microbiology professionals to ensure strong technical and compliance capability.- Compliance & Audit Readiness: Ensure adherence to GMP and regulatory requirements. Serve as Subject Matter Expert (SME) during client and regulatory audits (USFDA, MHRA, etc.).- Documentation & Data Integrity: Prepare, review, and maintain SOPs, protocols, and microbiology reports. Ensure data accuracy and management through LIMS.- Continuous Improvement: Analyze microbiological data to identify trends and lead initiatives for process and contamination control improvement.Preferred Profile- M.Sc. / M.Tech in Microbiology, Biotechnology, or related discipline.- 15–21 years of experience in sterile pharmaceutical microbiology (Injectables / Parenterals).- Proven experience facing USFDA or other regulatory audits.- Exposure to Contamination Control Strategy (CCS) implementation in sterile environments.- Strong knowledge of GMP, GLP, and QMS principles.- Excellent leadership, analytical, and communication skills.Why Join UsBe part of a forward-thinking pharmaceutical organization where quality, compliance, and innovation drive success. Lead initiatives that directly impact product sterility, patient safety, and global regulatory excellence.

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