· Division - Moraiya· Department - Quality Control· Category - Staff· Qualification - B.Sc./M.Sc./B.Pharma/M.Pharma· Zydus Experience - Must have completed minimum 2 years (minimum 2 PMS rating in current role)Job Responsibilities:1. To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI.2. To plan routine activities under consultation with respective section head.3. To review all analytical raw data and associated documents related to testing as per the approved procedure for its accuracy along with electronic data and audit trails wherever applicable.4. To review the adequacy of all raw data.5. To review all Analytical Data.6. To report any discrepancy noticed while review and follow the deviation reporting procedure as applicable. All such incidents or deviations reporting shall be discussed with analyst and section head.7. To review and discuss with analyst and section head, all OOS /OOT/ Incident as per defined procedures.8. To initiate the investigation OOS/OOT/Incident as per defined procedures and prepared the report for the same.9. To review protocol related to quality control testing.10. To ensure the raw data printout quality.11. To report any data integrity issues immediately on discovery to section head, quality control head and QA in QC.12. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.13. To keep himself updated with current regulatory requirements and train the subordinates and colleagues for the day-to-day activities as well as regulatory requirements.14. To co-ordinate with regulatory affairs personnel as and when required.15. To keep the things and his work area clean and tidy and get involved for routine trouble shooting (if any).16. To perform predictive stability analysis on data generated for stability study.17. In absence of me designee will be responsible for the responsibility lies with me.18. To conduct daily dialogue19. To take a round of shop floor and verify the documents for critical aspects in QC area like online entry (on time) and accuracy, correctness, traceability & legibility of data.20. Any other specific work or assignment as given by the section head/department head. 21.To escalate any failures and overdue activity that can have a potential impact on product quality to his or her immediate reporting authority.22. To Monitoring of Hypothesis /extended study of laboratory investigation.
