Assistant Manager - Corporate Quality Assurance (API)

1. To review the change controls and complete the CQA/SQA assessments, submit the actions for HOD approval and QA verification, perform and complete the assigned actions, submission of completed actions to closure. Closure of assigned Govandi change assessments.

2. Review of Specifications for raw/packaging material, in-process/intermediate, finished API, working standard, GTPs etc. in DocuSign. Master and making effective through DocuSign, distribution of controlled copies to site and CFTs.

3. To perform the TWD owner related activities for change control, deviations, CAPA etc.

4. To log the Customer complaint in the TWD.

5. To handle Recall/ Mock recall related activities for API sites.

6. To handle the user management for LIMS software across all the USV sites.

7. Review, Master, effective, control, issuance, retrieval, and obsolete of the master formula for API and intermediate.

8. Coordination with cross-functional departments, review and ensure timely completion of Customer Questionnaires / Regulatory Agencies Questionnaires (Vendor / Supplier questionnaires, Pre-audit Questionnaire, Supply chain Integrity Questionnaire), Customer queries and other declaration like TSE/BSE, GMO, Residual solvents, Genotoxic Impurities etc.

9. Handling SAP code creation/extension/modification related activities in SAP S4 HANA software.

10. To prepare quarterly trend for change control related to Govandi i.e. corporate function.

11. Management of CTL Quality Agreements, Site Specific CTL List, Scheduling CTL Audits/Compliance, Maintaining CTL Quality agreement logs.

12. To participate in self-audits at USV manufacturing sites and self-audits of corporate functions as per annual self-audit schedule as per requirement.

13. To prepare/ revise Corporate SOPs and impart training to respective assigned roles.

14. To perform allotted quality audits of new vendor/alternate vendors proposed in the vendor audit schedule and their compliance verification in timely manner.

15. To perform functional/cGMP trainings as per need.

16. Shall perform any other work assigned by HOD/Section Head.