Senior Manager Quality Control Microbiology

Manager / Lead – Microbiology (Sterile Pharma)

📍 Location: Chakan , Pune 🏭 Industry: Pharmaceuticals (Sterile / Injectables)

About the Role

Microbiology Leader

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.