Dy Mgr / Mgr - QC (QMS)
Job Description
Position Vacant : Manager - Quality Control (QMS)
Job Responsibilities:
1. Review of Logbooks, Test data sheets, and data generated in Quality control Analytical department.
2. Routine inspection of Quality control department to check and ensure compliance as per cGMP.
3. Routine inspection of QC schedule for execution.
4. Preparation and review of protocol and report for validation, verification, Characterization, hypothetical testing and Force degradation studies.
5. Initiation of deviations, change controls, Incidents and CAPA in trackwise digital..
6. Ensure timely investigations and closure of all deviation, OOS, OOT, CAPA and change controls.
7. Tracking of activities mentioned in CAPA and checking of CAPA effectiveness.
8. Tracking of QMS documents in trackwise digital.
9. Training of personnel in various aspects of cGMP and cGLP as per requirements.
10. Conduct training to all the CFTs and other personnel on Investigation outcome, SOPs, Protocols, and SAPs.
11. SOP preparation activities to be carried in SAP S4 HANA.
12. To check analysis/activity performed by analyst.
13. Review of Certificate of Analysis.
14. Preparation of Audit compliance and walk through reports.
15. Ensuring the recording of the Temperature and Humidity is properly being maintained and review the documents related to it.
16. Responsible to assign job responsibilities to the QC personnel.
17. To participate in Self-inspection/ Walkthrough/Internal and external audit program.
18. Activities assigned by Superior and HOD.
19. Activities to be carried out according to LIMS.