Executive - DQA (Developmental Quality Assurance)

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. M.Sc with 7 to 10 years of experience in QC/QA function within a pharmaceutical manufacturing organisation.

2. Strong technical knowledge of analytical instruments such as HPLC, GC, LCMS, GCMS, ICPMS and AAS.

3. Sound understanding of regulatory requirements including USFDA, EMA, ICH, GDP, GLP, GMP and 21 CFR Part 11

4. Detail oriented with strong documentation and review skills.