- Management and Maintenance of GLP & GMP in accordance with Norms in QC Dept
2. Adherence & Review of SOP and STPs.
3. Allocation of Work and Planning on a Daily Basis
4. Keeping all Analytical Instrument updated and Ready for Usage/Audits
5. Analysis and Evaluation of RM/PM/FP’s as per process and defined timelines and Approval/Rejection and furnishing reports of the same.
6. Reviewing and Approving of stability Protocol & data generated from time to time.
7. Preparation and Timely completion of AMC & Calibration schedule
8. Ensuring qualification of working standard and procuring the reference standard, impurity standards, and other laboratory required items.
9. Investigation of the OOS/OOT/OOC occurred in the laboratory or other Laboratory Incidents.
10. Carrying out in market complaint Investigations
11. Responsible for maintaining and continuous improvement in 21CFR compliance.
12. Interdepartmental Coordination for Timely Dispatches and External Laboratories for Analysis.
13. The accomplishment of all documentation as per the defined timelines
14. Compliance with GLP and Safety Norms.
15. Training/Coaching team for better performance
16. Review and approve the analytical method transfer/validation/verification protocols and reports.
17. Responsible for review and approval of instrument qualifications and its compliance.
18. Ensure the Analytical Method validations as well as method transfers are conducted with an approved protocol and duly documented and approved.
19. Regularly supporting and providing the data as per the requirement from customer and regulatory.
20. Develop& prepare work procedures to minimize OHS risks and adverse environmental impact.
21. Involve the regulatory and customer audits to provide the answers for queries.
22. Ensure the data integrity checks are conducted regularly to evaluate the health of the system and implement actions as required.
Qualification: B.Sc/MS/M.Sc Chemistry
Experience: 12-15 Years