Executive - Vendor Qualification

Role & responsibilities

1. To ensure compliance of vendor Qualification system.

2. To perform vendor/ contract laboratory/ contract manufacturer/external service providers audit & ensure audit compliance.

3. To review vendor qualification documents as per requirements.

4. To perform required transaction in SAP system for vendor qualification.

5. To perform Q-info related activities in SAP system.

6. Initiation of change control and deviation related to vendor qualification, contract manufacturing and external services.

7. To perform raw material code related activities.

8. Preparation of vendors audit planner and vendor assessment of KSM and intermediate for each year.

9. To ensure the compliance status of contract manufacturing sites and agreements.

10. Handling and archival of vendor qualification documents in compactor.

11. To perform the required transactions in SAP for data transcription.

12. To maintained list and audit planner of external quality control laboratories and list of external quality control services.

13. To perform the qualification and audit of external service provider and contract laboratories.

14. To maintained the list of External service provider.

15. To perform the activities as per requirement using applicable software(s).

Preferred candidate profile

1. 7-10 years of experience in vendor qualification / Change Control / QA within pharma or life sciences.

2. Working knowledge of SAP, change control processes and audit management.

3. Prior exposure to contract manufacturer / CL qualification and external service provider audits preferred