This role is responsible for performing in-process, utility, environmental, and finished product microbiological testing in compliance with approved procedures, Good Manufacturing Practices (GMP), and applicable regulatory requirements. The incumbent evaluates microbiological test results for accuracy, precision, and compliance with predefined specifications to ensure product quality, safety, and integrity. The position supports the identification of quality concerns through routine monitoring, investigation, and timely escalation of microbiological deviations. Activities are performed within a structured Quality Management System (QMS) aligned with 21 CFR Parts 210 & 211 and applicable Indian and international pharmaceutical regulations on Positive Microbiology practices.
Key Responsibilities
Microbiological Testing & Analysis
• Perform microbiological analyses including: • Bioburden Testing
• Microbial Limit Test (MLT)
• Sterility Testing
• Bacterial Endotoxin Test (BET)
• Water Analysis
• Other routine microbiological evaluations as per approved procedures.
• Review and interpret analytical results against established specifications and acceptance criteria.
• Ensure all testing activities are executed and documented in accordance with current GMP, GDP, and laboratory procedures.
Environmental & Utility Monitoring
• Conduct environmental monitoring of microbiology laboratories, cleanrooms, and controlled manufacturing areas.
• Perform water sampling and microbiological analysis as per approved SOPs, protocols, and sampling plans.
• Maintain complete and accurate records related to environmental monitoring and utility testing.
Culture & Media Management
• Prepare, manage, and maintain microbiological media inventory and reconciliation records.
• Perform culture maintenance activities and ensure proper preservation of microbial cultures.
• Conduct Growth Promotion Testing (GPT) of microbiological media and document observations and results.