Senior Manager of Quality Control and Microbiology

8 hours ago

pimprichinchwad, India beBeeMicrobiologist Full time

Job SummaryLead a team of microbiology professionals to ensure strong technical and compliance capability.Risk Management: Identify, assess, and mitigate microbiological risks across raw materials, utilities, processes, and finished products.Laboratory Operations: Oversee daily microbiology lab activities—testing, method validation, equipment and cleaning validation, EMPQ, microbial identification, and trending.Problem Solving: Investigate and resolve out-of-specification results, deviations, and environmental monitoring non-conformances. Implement Corrective Actions.Team Leadership: Supervise, mentor, and develop the skills of microbiology professionals to meet regulatory requirements.Compliance & Audit Readiness: Ensure adherence to Good Manufacturing Practices (GMP) and regulatory requirements. Serve as Subject Matter Expert during client and regulatory audits.Documentation & Data Integrity: Prepare, review, and maintain Standard Operating Procedures (SOPs), protocols, and microbiology reports. Ensure data accuracy and management through Laboratory Information Management Systems (LIMS).Continuous Improvement: Analyze microbiological data to identify trends and implement initiatives for process and contamination control improvement.The ideal candidate will have a Master's degree in Microbiology, Biotechnology, or a related field and at least 15-21 years of experience in sterile pharmaceutical microbiology.

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