Senior Officer

23 hours ago

Dadra amp Nagar Haveli, India Stellar Formulations Full time

Role & responsibilities

  1. Microbiological Analysis
  2. Conduct microbial limit test, sterility test, endotoxin testing, and bioburden analysis on raw materials, in-process, and finished products.
  3. Perform water testing for purified water and potable water systems as per pharmacopeial standards.

  4. Conduct environmental monitoring of cleanrooms and controlled areas, including settle plates, active air sampling, and surface monitoring.

  5. Documentation & Compliance

  6. Prepare and review analytical reports, logbooks, and records in line with GDP (Good Documentation Practices).
  7. Ensure compliance with GMP, WHO, USFDA, MHRA, and other regulatory guidelines.

  8. Handle SOP preparation, revision, and adherence for microbiology operations.

  9. Equipment Handling & Calibration

  10. Operate and maintain autoclaves, LAF, incubators, BOD chambers, particle counters, and microbiological instruments.

  11. Ensure timely calibration and qualification of instruments.

  12. Quality & Investigation

  13. Support OOS (Out of Specification), OOT (Out of Trend), and deviation investigations related to microbiological testing.

  14. Assist in CAPA implementation for microbiology-related observations.

  15. Training & Safety

  16. Provide training to junior team members on microbiology practices and SOPs.
  17. Follow and enforce safety guidelines for handling microbial cultures and hazardous materials.

Key Skills & Competencies:

  • Strong knowledge of pharmacopeial methods (IP, BP, USP, EP) and cGMP guidelines.
  • Hands-on experience with microbial testing techniques and environmental monitoring.
  • Good understanding of sterile and non-sterile product testing requirements.
  • Analytical mindset, attention to detail, and good documentation skills.
  • Ability to work in team environment and handle regulatory audits confidently.

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