Senior Manager Quality Control Microbiology

15 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 ResponsibilitiesRisk 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 ProfileM.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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