Job Title: Manager / Senior Manager – Microbiology (QC) Location: Indore – Regulated Pharma Manufacturing Plant Department: Quality Control – Microbiology Reporting To: Head – Quality Control Job Type: Full-Time | Managerial Level Job Purpose To lead the Microbiology function in the QC department, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements (USFDA, EU-GMP, MHRA, WHO, etc.), and company quality standards by overseeing microbiological testing, environmental monitoring, sterility assurance, and microbiological risk assessments. Key Responsibilities - Leadership & Team Management Lead and manage the microbiology team, ensuring training, development, and performance management. Provide technical guidance to resolve complex microbiological issues. - Compliance & Regulatory Readiness Ensure strict adherence to cGMP, GLP, and data integrity principles in all microbiological activities. Prepare and face regulatory inspections (USFDA, MHRA, EU, WHO-GMP) and ensure readiness through gap analysis and internal audits. - Microbiological Testing Oversight Supervise And Review All Microbiological Testing Activities Including Environmental Monitoring (EM) Water Testing (WFI, PW, HVAC, Compressed Air) Sterility Testing and Bacterial Endotoxin Testing (BET) Microbial Limit Tests (MLT) Bioburden & Identification of Isolates Disinfectant Effectiveness Studies and Media Growth Promotion Testing - Documentation & Quality Systems Review and approve microbiological protocols, SOPs, specifications, and reports. Investigate microbiological deviations, OOS/OOT results, and implement appropriate CAPAs. Ensure Timely Execution Of Qualifications For Microbiology Lab Equipment. - Risk Assessment & Process Improvements Lead microbial risk assessments for manufacturing processes and facility controls. Identify and implement continuous improvement initiatives within the microbiology lab. - Coordination & Communication Collaborate with QA, Production, Engineering, and other departments for hygiene, contamination control, and new product support. Provide inputs during product and process changes, validations, and tech transfers. Key Skills & Competencies In-depth knowledge of microbiological testing methods and aseptic techniques. Strong understanding of cleanroom classification, contamination control, and regulatory standards. Expertise in sterile and non-sterile product microbiology. Leadership and people management capabilities. Strong analytical, documentation, and communication skills. Educational Qualifications M.Sc. (Microbiology) / M.Pharm (Microbiology) or equivalent qualification in a life science discipline. Experience 10–15 years of relevant experience in QC Microbiology in a regulated pharmaceutical environment, with at least 3–5 years in a leadership/managerial role. Preferred Certifications / Trainings Certified training in cGMP, Data Integrity, Aseptic Practices, or Sterility Assurance preferred. #J-18808-Ljbffr