1. Microbiological Testing

• Conduct routine Microbial Limit Testing (USP <61> & <62>) of Raw materials, Intermediates and Finished products and Water (Raw water, Purified water and WFI).
• Perform Environmental Monitoring of Microbiology Laboratories and Manufacturing areas.
• Daily calibration of all Microbiology Instruments/Equipment.
• Perform Media Preparation, Growth Promotion Test, Culture maintenance and Stock preservation.
• Perform Sterility Testing (USP <71>) for the parenteral preparations.
• Perform Bacterial Endotoxin Testing (USP <85>) for finished products and water.
• Perform Antimicrobial Effectiveness Testing (AET) (USP <51>).
• Antibiotic Microbial Assay (USP <81>).
• Perform Disinfectant Efficacy Testing (USP <1072>).
• Develop and Validate new Microbiological test methods.

2. Documentation & Compliance

• Maintain GMP and ISO 17025 compliant documentation.
• Prepare and review test reports and Certificates of Analysis (CoA).
• Investigate OOS, OOT and deviations for Microbiological test results.
• Ensure ALCOA+ data integrity principles.
• Participate in internal and external audits.

3. Client & Regulatory Support

• Meet client turnaround times (TAT)
• Communicate technical queries and results to the clients.
• Support regulatory inspections.

4. Required Qualifications

• Master's degree in microbiology.