GAT - QC Micro

1. To follow Good Documentation Practices with no data integrity related observations. 2. Microbial Limit Test of Samples Raw Material, Finish Product, In-process, Stability, Packing Material Hold Time Study, Process Validation, Bio-burden and Swab. 3. Perform Growth Promotion Test of Media, Culture enrichment, Culture Quantification and Sub Culturing of Microorganisms 4. Preparation of culture media, media plates & slants. 5. Maintain Media Re-conciliation and Destruction record. 6. Temperature/differential pressure monitoring in Microbiology laboratory. 7. To maintain the records of Microbiology laboratory. 8. Sampling and microbiological analysis of Water Samples. 9. Perform BET WFI, In-Process Samples, Stability and Finished Goods Samples. 10. Environmental monitoring of Production Area (Non Sterile & Sterile) and Microbiology Laboratory. 11. Environmental monitoring and Plates Transfer and Observation of Production Area (Sterile & Non Sterile) and Microbiology Laboratory and Complete the Reports. 12. Observations of Water Analysis, Microbial limit Test and Environmental Monitoring and recording in reports. 13. To observe and follow all safety measure as applicable within the area of operations and in the premises.

14. All Equipment/Instrument operation, Verification, Calibration & Validation.