Sr. Executive Third Party Operation

Role & responsibilities

1. To ensure smooth third party Operation for all LL / TP location.

2. Responsible for third party process activities for OSD, solid oral dosage form.

3. To coordinate with LL / TP site for technical documents.

4. To be present and ensure production and packaging activities at LL/TP location.

5. To coordinate with PPMC / QA / QC / TP-LL location for smooth operation.

6. To prepare / review PIF (Product information form) and circulate with all stake holder, after approval timely share it with LL sites.

7. To ensure all activities to be done as per PIF. To maintain PIF file in soft and hard copy.

8. To maintain valid product and site license copy.

9. To prepare BMR / BPR for LL products and share it to LL site after final approval.

10. For ant changes / deviation ensure all should be handled through relevant QMS and its CAPA if any.

11. To ensure in-process at various stage of production and packaging and ensure its online documentation.

12. Before batch release ensure BMR and BPR and its relevant documents are reviewed and complied.

13. To ensure LL / TP site for readiness of audit.

14. To be present in process validation activities at LL/TP sites.

15. To coordinate with third party manufacturers for commercial products during technology transfer. To be present during technology transfer procedure at LL sites.

16. Identifying and executing continuous improvement opportunities at third party sites and communicate with TP and technical head.

17. To ensure products should be manufactured and packed and as per cGMPs, SOP's, relevant government regulations, and current industry standards.

18. To be part of audit team for RM vendor and LL-TP site.

19. Risk Management: • Identifying and assessing risks associated with third-party suppliers, including supply chain disruptions, quality issues, regulatory compliance and issues with CAPA.

20. Continuous Improvement: • Monitoring LL / TP site against key performance indicators (KPIs) and benchmarks.

21. Regulatory Compliance: • Ensuring that all third-party suppliers comply with relevant regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Distribution Practices (GDP), and other applicable regulations.

Preferred candidate profile