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:
1. Leadership & Team Management
Lead and manage the microbiology team, ensuring training, development, and performance management.
Provide technical guidance to resolve complex microbiological issues.
2. 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.
3. 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
4. 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.
5. Risk Assessment & Process Improvements
Lead microbial risk assessments for manufacturing processes and facility controls.
Identify and implement continuous improvement initiatives within the microbiology lab.
6. 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.
