Senior Manager Quality Control Microbiology

7 hours ago

PunePimpriChinchwad Area, India Enzene Biosciences Ltd Full time

Manager / Lead – Microbiology (Sterile Pharma) 📍 Location: Chakan , Pune 🏭 Industry: Pharmaceuticals (Sterile / Injectables) About the Role We’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 Us Be 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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