1. Job Purpose
To perform and supervise microbiological testing and laboratory activities in accordance with approved SOPs, STPs, specifications, GMP, GLP, data integrity requirements, and applicable regulatory guidelines. The role includes microbiological analysis, environmental and water monitoring, documentation, investigation support, and supervision of microbiology activities.
2. Key Responsibilities
A. Microbiological Testing
Perform microbiological testing of raw materials, finished products, water, and other applicable samples as per approved specifications and STPs.
Perform Microbial Limit Test (MLT), TAMC, TYMC, bioburden, pathogen, sterility, BET, and microbial assay testing, as applicable.
Perform pH, conductivity, and TOC testing of water samples as per approved procedures.
Ensure proper sampling, handling, identification, storage, and disposal of microbiological samples.
B. Environmental & Water Monitoring
Perform Environmental Monitoring (EM) including settle plate, air, surface, and personnel monitoring, as applicable.
Perform microbiological analysis of Raw Water, Purified Water, ETP Water, and Drinking Water.
Monitor and record laboratory temperature, RH, differential pressure, and refrigerator temperature.
Observe and evaluate microbiological plates and maintain environmental monitoring records.
Report any OOS, OOT, alert/action level excursion, contamination, or abnormal observation to the reporting manager.
C. Media, Culture & Equipment Management
Prepare, sterilize, store, and reconcile microbiological media and perform Growth Promotion Test (GPT).
Manage reference cultures, working cultures, sub-cultures, and culture records.
Ensure availability and proper storage of media, reagents, cultures, and microbiology consumables.
Ensure proper operation, calibration, maintenance, and qualification of microbiology laboratory equipment.
D. Documentation & Quality System
Maintain microbiology raw data, worksheets, logbooks, registers, reports, and other GMP records.
Review microbiological data and reports for accuracy, completeness, and compliance.
Prepare, review, and periodically update Microbiology SOPs, formats, protocols, and related documents.
Ensure compliance with GMP, GLP, GDP, data integrity, and laboratory safety requirements.
3. Section In-charge Responsibilities
Supervise daily microbiology laboratory activities and ensure timely completion of testing.
Review microbiology raw data, analytical reports, EM results, water testing, MLT, sterility, and BET results.
Participate in OOS/OOT, deviation, contamination, and microbiological failure investigations and provide technical inputs.
Monitor microbiological trends and report adverse or recurring trends to the Head – QC.
Train and guide microbiology analysts and support analyst qualification.
Ensure effective implementation of microbiology SOPs and laboratory procedures.
Support CAPA, change control, audits, inspections, and other quality-system activities related to microbiology.
4. Key Competencies
Strong knowledge of Microbiology and QC laboratory practices.
Practical knowledge of MLT, EM, water testing, sterility, BET, media, and culture management.
Good understanding of GMP, GLP, GDP, and data integrity.
Good documentation, analytical, investigation, and problem-solving skills.
Ability to train, guide, and supervise microbiology personnel.
Strong quality and compliance orientation.
5. Key Performance Areas (KPIs)
Timely and accurate completion of microbiological testing.
Compliance with SOPs, specifications, GMP, GLP, and data integrity requirements.
Effective Environmental and Water Monitoring.
Accurate and timely microbiology documentation and data review.
Timely reporting and investigation support for OOS/OOT and deviations.
Effective media, culture, and equipment management.
Analyst training and qualification.
Microbiology laboratory audit and inspection readiness.
6. Authority & Accountability
The Sr. Executive – Microbiology is accountable for the accurate execution, supervision, review, and documentation of microbiological activities and for ensuring compliance with approved procedures and quality requirements. Any OOS/OOT result, deviation, contamination event, or significant microbiological abnormality shall be promptly escalated to the Head – QC.
