Roles & Responsibilities 

1. Review and approve microbiological test records, reports, and data.
2. Perform real-time verification of environmental monitoring, utility monitoring, and microbial plate counts reading.
3. Review and verify BET (Bacterial Endotoxin Test) results and associated calculations.
4. Ensure compliance with cGMP, GDP, data integrity, and laboratory SOP requirements.
5. Lead OOS, OOT/OOL, laboratory incidents, deviations, and contamination investigations.
6. Perform root cause analysis and ensure timely implementation of CAPAs.
7. Oversee Environmental Monitoring (EM) and utility monitoring programs, including trend review.
8. Review and trend microbiological data to identify adverse trends and potential risks.
9. Coordinate microbiological method validation, method verification, and method suitability studies.
10. Execute and review general microbiology studies, including media qualification, GPT, disinfectant efficacy, hold-time, recovery, and recovery efficiency studies.
11. Ensure qualification, calibration, and maintenance of microbiology laboratory equipment.
12. Support sterility assurance activities, CCS implementation, and aseptic process monitoring.
13. Review change controls, risk assessments, and quality system documentation from a microbiological perspective.
14. Ensure analyst training, qualification, and periodic competency assessments.
15. Support internal audits, customer audits, and regulatory inspections as a microbiology SME.

NOTE: Candidate should have good experience in a sterile injectable FDA Approved company and should have actively participated in FDA and other regulatory inspections.

Work Location

Medchal, Hyderabad.

Qualifications & Experience

• Bachelor’s/master’s degree in pharmacy, Chemistry, Biotechnology, Microbiology  or related discipline.

Experience

• 5–8years of experience in IPQM within bio-pharmaceutical manufacturing.