Officer, QC Environment Monitoring / MIcrobiology

Description 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 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