Job Description:

1. To ensure products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice.
2. To review and authorization of critical documents like SMF, VMP, SOP, Specification, Validation Protocol/report, BPCR, Stability Protocol/report, etc.
3. To review and approval of Change control, Deviation, MFR, Technology Transfer, Market Complaints, Failure Investigation, APQR.
4. To handle & management of complaint / return of goods / product recall as per approved / mutually agreed procedure with contract giver / agency.
5. To examine Complaints about products and to ensure the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.
6. To plan periodic management review with the involvement of senior management for the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself.
7. Responsible for Final batch release / reject by taking in to account the results of product and processes monitoring, investigation of deviations, and, with a view to taking preventive action to avoid potential deviations occurring in the future and complying to the requirements.
8. To ensure training needs are identified and relevant trainings are imparted to all levels appropriate to their duties including GMP regulation training.
9. To train and certify internal trainers and auditors and to participate in self inspection & its effectiveness monitoring.
10. To ensure all activity is running according to company SOP, protocol and with written procedure and complying to applicable norms.
11. To facilitate Quality Risk Management exercise and to ensure steps are timely taken to minimize/avoid failures.
12. To communicate with Management for necessary resources/facilities availability to achieve desired standards and output.
13. To help creating and maintaining good organization and Quality culture.
14. To ensure design, operation & monitoring of process & systems in order to comply with the principles of Data Integrity.
15. To ensure arrangements are made for the manufacture, supply and use of the correct starting and packaging materials, the selection, monitoring & approval of suppliers and auditing them as required.
16. To ensure product quality is comply through out its lifecycle.
17. To monitor effectiveness of QMS and necessary CAPA is implemented.
18. To review and approval of Method of analysis, Specification, Stability report, OOT and OOS.
19. To monitor and control outsourced testing activities.
20. To ensure Production and control operations are clearly specified and Good Manufacturing Practice adopted.
21. To set implementation priorities and develop action plans according to goals and target set by the management.
22. To ensure continual improvement is facilitated through the implementation of quality improvements appropriate to the current level of process and product knowledge.