Officer, QC Environment Monitoring / MIcrobiology

Essential 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

Qualifications

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