Senior Manager Quality Control Microbiology
1 day ago
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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