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
Solid 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.
Robust audit handling and team management experience.

Pay: ₹50,000.00 - ₹60,000.00 per month

Perks:
Cell phone reimbursement
Food provided
Paid sick time
Provident Fund

Work Location: In person

📌 Qc Microbiologist Injection Fda Aprooved Paonta Sahib
🏢 Pharmaceuticals
📍 Paonta Sahib