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