Zydus Lifesciences Hiring For QC QMS
Zydus Lifesciences Hiring For QC QMS
Section Head - (QC QMS) RM/PM - Vaccines
Qualification: M. Sc. Chemistry / M. Pharm / Postgraduate with Relevant Experience
Experience: 10-15 years
Job Location : Zydus Biotech Park, Changodar, Opp. Ramdev Masala, Sarkhej Bavla, NH BA, Changodar, Ahmedabad-382213, Gujarat
Job description
1. To be accountable as Section head in planning and supervising the sampling, testing & release of RM & PM
2. To ensure adequate number of analysts and reviewers are qualified for testing and review in chemical section (including water), ensure on job training and track to monitor the team operations.
3. To ensure analysis and release of the batches are within the defined SLA and as per standard productivity.
4. Review and Release of raw materials, packing materials, in-process and finished products in LIMS and SAP as and when required.
5. To ensure compliance with the defined cGMP and GLP requirements and to ensure revision of Specifications/ SOPs/ STPs/GTPs according to compendial requirements as and when required.
6. Act as a Super User for Laboratory Information Management System (LIMS) of QC Analysis.
7. To ensure sample management (Sample receiving and timely release of TRS)
8. To ensure zero data integrity issue within Chemical section.
9. To oversee the calibration and validation/ PM of equipment/ instrument done as per schedule, Breakdown reporting/ closure and to coordinate with engineering maintenance department or third-party lab as and when required.
10. To coordinate and ensure Installation, Qualification, Calibration and Maintenance of equipment/ instruments.
11. To ensure/procure adequate stock inventory of consumables/ reagents/chemicals/kits/stationary/ other miscellaneous items
12. To review and monitoring of Temperature/Humidity and other critical parameters
13. To execute PR/PO for CMC/AMC of instruments, Third party calibration, third party samples etc.
14. Monthly verification shall be carried out for near to expire materials of concern section and if required put the material in lock and key.
15. Ensuring cleanliness/ all-time audit readiness of the labs/ areas allocated and EHS/ Bio-safety compliance.
16. To ensure qualified third-party labs for outsourced tests
17. To oversee the manual paper-based documentation, LIMS and computerized systems for compliance
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