DescriptionEssential Functions
- Perform microbiological testing of APIs, purified water, and environmental samples as per approved specifications and methods.
- Conduct sampling and testing of water systems (PW) and environmental monitoring (air, surface, personnel) in classified areas.
- Carry out microbial limit tests (MLT), sterility testing, endotoxin testing, and other microbiological assays.
- Ensure accurate and timely documentation of test results in LIMS and laboratory records.
- Maintain and calibrate microbiological instruments (e.g., incubators, autoclaves, particle counters, air samplers) as per SOPs.
- Participate in investigations related to microbial contamination, OOS, deviations, and incidents.
- Ensure compliance with GLP, GDP, and cGMP in all microbiological activities.
- Maintain aseptic techniques and laboratory hygiene, including proper use of PPE and biosafety protocols.
- Support review and archival of microbiological data and records as per data integrity norms.
- Carry out any other assignments allocated by the QC Head or Designee.
Additional Responsibilities
- Assist in method validation, verification, and transfer of microbiological methods.
- Support preparation and revision of SOPs, specifications, and microbiological methods.
- Participate in internal and external audits, providing relevant microbiological data and documentation.
- Ensure proper retention, reconciliation, and disposal of microbiological samples and cultures.
- Support trending and analysis of microbiological data (e.g., EM trends, water system trends).
- Coordinate with production and QA teams to ensure timely microbiological clearance and batch release.
- Report any equipment malfunctions or microbiological concerns to the supervisor promptly.
Skills:
- Microbiological Testing (MLT, Sterility, Endotoxin) – Intermediate to Advanced
- Environmental Monitoring & Water Testing – Intermediate
- Instrument Handling (Incubators, Autoclaves, Air Samplers) – Intermediate
- LIMS Operation and Data Entry – Intermediate
- Handling and Review of Microbiological Documentation – Intermediate
- OOS/OOT/Deviation Investigation Participation – Intermediate
- Good Laboratory Practices (GLP) – Advanced
QualificationsQualifications
Education:
- M.Sc – Microbiology / Biotechnology – Preferred
- B.Pharm / M.Pharm – Acceptable with strong microbiology background
Experience:
- 4 to 8 years of relevant experience in microbiological testing in an API
