Senior Manager Quality Control Microbiology

1 day ago


PunePimpriChinchwad Area, India Enzene Biosciences Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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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