Job Description – Approved QC Microbiologist (Injection Plant)
Position: Approved QC Microbiologist
Department: Quality Control – Microbiology
Industry: Pharmaceutical Injection Plant
Location: Paonta Sahib
Qualification: M.Sc. (Microbiology) / B.Sc. or M.Pharm (as per regulatory requirements)
Experience: 8–12 Years in a sterile injectable manufacturing facility
Key Responsibilities
- Perform and review all microbiological testing for raw materials, water systems, environmental monitoring, finished products, and stability samples.
- Ensure compliance with cGMP, GLP, and regulatory requirements (WHO-GMP, Schedule M, and other applicable guidelines).
- Monitor and trend environmental monitoring data for classified cleanrooms.
- Oversee Water System Monitoring (Purified Water & WFI), compressed gases, and utility microbiological testing.
- Review and approve sterility test, bioburden, bacterial endotoxin test (BET), and microbial limit test results.
- Manage media preparation, growth promotion testing, culture maintenance, and microbial identification.
- Investigate OOS, OOT, deviations, contamination events, and implement CAPA.
- Review SOPs, protocols, reports, specifications, and validation documents.
- Support aseptic process simulation (Media Fill) activities and microbiological validation studies.
- Train microbiology team members and ensure laboratory compliance.
- Coordinate with QA, Production, and Engineering during audits and inspections.
- Face regulatory and customer audits and provide microbiology-related documentation.
Required Skills
- Strong knowledge of sterile injectable manufacturing and microbiological quality systems.
- Hands-on experience with Sterility Testing, BET, Environmental Monitoring, Water Testing, and Media Fill.
- Sound understanding of cGMP, GLP, data integrity, and documentation practices.
- Good leadership, communication, and investigation skills.
Preferred Candidate
- Experience in a USFDA/EU-GMP/WHO-GMP approved sterile injection facility.
- Proven experience as an Approved QC Microbiologist in an injectable manufacturing plant.
- Strong audit handling and team management experience.
Pay: ₹50,000.00 - ₹60,000.00 per month
Benefits:
- Cell phone reimbursement
- Food provided
- Paid sick time
- Provident Fund
Work Location: In person
