1.Key Responsibilities
A. Microbiological Testing
Perform Microbial Limit Test (MLT), microbial count, pathogen testing, and bioburden testing of raw materials and finished products as per approved specifications and STPs.
Perform Bacterial Endotoxin Test (BET), sterility testing, and microbial assay, as applicable.
Perform pH, conductivity, and TOC analysis of water samples as per approved procedures.
Ensure proper sampling, identification, handling, storage, and disposal of microbiological samples.
B. Water & Environmental Monitoring
Perform sampling and microbiological analysis of Raw Water, Purified Water, ETP Water, and Drinking Water.
Perform Environmental Monitoring (EM) using settle plates and other approved methods.
Perform personnel and surface monitoring, where applicable.
Monitor and record temperature, RH, differential pressure, and refrigerator temperature.
Observe, record, and report MLT and environmental monitoring results as per approved procedures.
C. Media & Culture Management
Prepare, sterilize, store, and reconcile microbiological media.
Perform Growth Promotion Test (GPT) and media sterility checks, as applicable.
Maintain and manage reference cultures, working cultures, and sub-cultures.
Maintain records for culture, media preparation, sterilization, and reconciliation.
D. Equipment & Documentation
Operate microbiology laboratory equipment as per approved SOPs.
Support calibration, preventive maintenance, and performance verification of microbiology instruments.
Maintain raw data, worksheets, logbooks, registers, and analytical reports.
Ensure accurate, complete, and traceable documentation as per GDP and data integrity requirements.
Report equipment malfunction, abnormal results, deviations, and laboratory incidents to the reporting manager.
E. SOP & Quality Compliance
Follow approved SOPs, STPs, specifications, GMP, GLP, and laboratory safety procedures.
Support preparation, revision, and periodic review of Microbiology SOPs.
Support investigations related to OOS/OOT, deviations, contamination, and microbiological failures.
Support microbiological trend analysis and periodic review activities.
Participate in internal audits, customer audits, and regulatory inspections as required.
2. Key Competencies
Knowledge of Microbiology and QC laboratory practices.
Practical knowledge of MLT, Environmental Monitoring, water testing, BET, sterility testing, and microbial assay.
Knowledge of media preparation, sterilization, GPT, and culture management.
Understanding of GMP, GLP, GDP, and data integrity.
Good documentation, analytical, and problem-solving skills.
Good communication and teamwork.
3. Accountability
Responsible for accurate and timely execution of microbiological testing, environmental monitoring, water analysis, media and culture management, equipment operation, and documentation. Any OOS/OOT result, deviation, contamination, equipment malfunction, or abnormal observation shall be promptly reported to the Sr. Manager – QC.
