Sr Executive-A (QC)
Navi Mumbai, MH, IN, 400613
1. Job role: Supervisor QC-Documentation & QMS2. Preparation of SOP’s and Validation protocols as and when required.3. Carry out calibration of the Instruments as per the laid down procedure.4. Daily Monitoring of Temperature, Humidity, Cleaning & pressure differential records review.5. Microbiological Analysis of Purified water, Potable water and Finished Product.6. Environmental Monitoring of Unit I, Unit II, Unit III, Stores and Microbiological department.7. Carry out qualification / requalification of equipment in Microbiological department.8. Review of the preparation of Media, Culture dilution, culture maintenance and Growth Promotion Test.10. Carry out MLT validations of the finished products.11. Review of the analysis and reports in the microbiology section.12. Work allocation and its implementation and to update the daily status to department head or section head.13. Carry out investigation for failure of microbiological analysis (Water, Environment, Product, Growth Promotion test) & Investigation for failure of water for chemical analysis.14. To initiate the change control and perform related activity.15. To initiate the deviation form and perform related activity.16. Initiate the CAPA and perform related activity.17. Training to be given to analyst as and when required.18. To carry out Trending data of Environmental Monitoring, Water as per frequency.19. To carry out Dirty / Cleaned equipment Hold time Study.20. Co-ordinate with QA, Production and Stores department for related activity.21. Co-ordinate with engineering department for maintenance activity.22. Preparation and Review of Certificate of Analysis (COA).23. Any other assignment allocated by the Department Head / Section head.24. Implementation of Good laboratory practices, Good documentation practices as per standard operating procedures in Microbiology laboratory.25. To follow Good Laboratory Practices as laid down in standard operating procedures in Quality Control.26. To review and update training calendar periodically.27. Implementation of Good laboratory practices, Good documentation practices as per standard operating procedures in Quality control department.28. Training to New joinee / existing employee in Microbiology department.