Quality Control - Deputy Manager (Biologics)

Role & responsibilities Analytical data review of in-process, Batch release and stability samples & planning of activities in the Instrumentation lab Trouble shooting of HPLC & UPLC instruments, maintaining of lab as per GLP GDP practices. Audit trail verification of APLE & UPLC 1. Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing. 2. Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3. Responsible for shift schedules and test planning activities. 4. Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5. Responsible for testing review and release of product samples by analytical techniques like CZE, HPLC, UPLC etc., 6. Responsible for handling of OOS, OOT, Incidents, LIRs, Change controls and Risk Assessments. 7. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 8. Responsible for training of QC analysts and new joiners related to product testing. 9. Review of analytical reports and work sheets related to product testing 10. Maintenance of all QC documents related to product testing. 11. Preparation and Review of reagents and buffers. 12. Responsible for GLP compliance. 13. Responsible for usage, monitoring and verification of all kinds of Laboratory log books 14. Responsible Sample management and Material management in Quality Control. 15. Stability Management. 16. Responsible for calibrations, validations and PMP of instruments related to product testing. 17. Preparation, execution and review of reference standard qualification. 18. Responsible for procurement and verification of reference standards stock and consumption records 19. Responsible for conducting internal audit of other departments as part of GMP compliance. 20. Responsible for general cleanliness of laboratory 21. Responsible for coordinating with IT department for ensuring the electronic data backup, data retrieval of instruments related to product testing. 22. Responsible for preparation for URS. 23. Responsible for Coordinating with inter and intra departments for technical discussions. 24. Responsible for samples sending and checking of outside laboratory reports. 25. Responsible for preparation and uploading of job responsibilities for new joinee or whenever employee job role change. 26. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 27. Any other responsibilities assigned by reporting officer and HOD. Preferred candidate profile