Microbiology Quality Control Lead

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

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.