Quality Assurance Senior Executive

To review/approve method development documents, specifications (FP/IP/RM/PM), test methods (FP/IP/RM/PM), method validation documents, method transfer documents, stability reports, certificate of analysis and any other analytical related documents.

2. To review and approve instrument qualification documents, calibrations documents, preventive maintenance documents, training planners, AMC planners. To ensure calibrations, preventive maintenance, AMC and trainings as per planners.

3. To prepare, review, approve, revise and control standard operating procedures and documents.

4. To handle change controls, incidents, deviations, corrective and preventive actions (CAPA), out of specifications (OOS), out of calibrations, breakdowns, customer queries.

(Experience on QMS software & LIMS preferred)

5. To prepare & review QMS trends.

6. To conduct cGMP trainings and SOP trainings for team.

7. To handle internal audits, customer audits, regulatory audits, vendor audits and ensuring audit documents completion.

8. To perform document management as per procedure & cGMP/GLP. Issuance, archival and management of LNBs, log books, forms, formats, registers and other required documents of formulation and analytical testing activities.

9. To perform user account management for instruments & perform admin related roles. To ensure data backup.

10. To review of audit trails.

11. To ensure compliance with respect to applicable procedures/guidelines.

12. To ensure good documentation practices.

13. Evaluation/assessment of Nitrosamine impurities in compliance with regulatory requirements.

14. To prepare/review organograms & site master file.

15. Experience on HPLC, UV, IR, DSC, TGA, XRD, PSA, NMR.