1. Implementation of Quality management system as per CGMP.
2. Preparation, review, revision and approval of SOPs.
3. Review, revision and approval of in-process & finished product specifications.
4. To co-ordinate for qualification (DQ/IQ/OQ/PQ) of equipments.
5. To plan for the process validation of existing products with production.
6. To ensure scheduled validation of the systems as per Validation Master Plan.
7. To ensure scheduled calibration of the systems as per calibration schedule.
8. Responsible for issuing & retrieval of batch Manufacturing Records (BMR & BPR), CAPA.
9. Investigation of market complaints, Product failure, Product recall & Return products.
10. Management of change control & deviations, Preparation & Approval of Site master file & Quality Manual.
11. Pre dispatch inspection (PDI) for Export & domestic market.
12. Loan license activities of loan license parties.