QC Microbiologist; Injectables

The QC Microbiologist will be responsible for planning, executing, and reviewing microbiological testing activities to ensure compliance with regulatory requirements for sterile and injectable products. The role requires strong expertise in sterility assurance, environmental monitoring, and microbiological testing in GMP-regulated environments.

• Perform and oversee sterility testing of injectable and sterile pharmaceutical products as per pharmacopeial requirements (USP, EP, IP).
• Conduct and review microbiological testing
  , including:
• Bacterial endotoxin testing (LAL)
• Growth promotion testing
• Manage Environmental Monitoring (EM) programs for clean rooms, including:
• Viable and non-viable monitoring
• Trend analysis and reporting
• Ensure compliance with aseptic techniques and sterile practices in microbiology laboratories.
• Investigate out-of-specification (OOS),
  out-of-trend (OOT), and microbiological deviations; perform root cause analysis and implement CAPA.
• Prepare, review, and approve microbiology-related SOPs
  , protocols, reports, and validation documents.
• Support media fill studies
  , cleaning validation, and disinfectant efficacy studies.
• Ensure laboratory compliance with cGMP, GLP, and data integrity requirements.
• Participate in and support regulatory audits and inspections (USFDA, EMA, WHO, MHRA, etc.).
• Train and mentor junior microbiology staff and ensure adherence to GMP practices.
• Coordinate calibration, qualification, and maintenance of microbiology laboratory instruments.
• Ensure proper documentation, review, and archival of microbiological records.

• Educational
  
  Qualification:
  
  
• Master’s degree in Microbiology or related life sciences (preferred).
• Experience:
• Minimum 10 years of hands‑on QC Microbiology experience, with strong exposure to injectable/sterile products
  .
• Technical Expertise:
• Sterility testing (isolator/LAF‑based)
• Endotoxin testing
• Aseptic practices
• Regulatory Knowledge:
• Strong understanding of global regulatory guidelines and pharmacopeias.
• Soft Skills:
• Strong analytical and problem‑solving skills
• Excellent documentation and communication abilities
• Ability to work independently and lead microbiology activities