发布 Jun 02, 2017 1 查看
1. Responsible for the implementation of GMP in the Factory & ensure planning & monitoring of all Quality Assurance functions that effect Process & Product Quality.
2. Participate in formulating and implementing Management decisions pertaining to the efficient and safe operation of the plant.
3. Review all technical & regulatory aspects of product development including appropriate material, process capability, suitably of production equipments, testing instruments, calibration of analytical apparatus, development of specification, retention of records.
4. Conduct periodic self inspection in conjunction with departmental heads of all factory operations as per cGMP requirements.
5. Set Departmental objectives with Manager/Officers.
6. Attend Management Meetings.
7. Ensure the maintenance of system for release and rejection of all incoming materials, machines and processes.
8. To ensure for test approval of all intermediate, bulk and finished products.
9. Ensure that master documents and standard operating procedures are kept up to date.
10. .To ensures that a system is available to recall any batch of product from sale or supply.
11. Qualify & Auditing of external suppliers, service providers.
12. Provide feed-back to production on matters relating to the quality of the products.
13. Maintain a constant dialogue with production to ensure awareness that quality is everyone's responsibility.
14. Ensure complaints relating to quality of products are reviewed and authorize corrective action.
15. To ensure ISO 9001: 2015 implementation in Factory.
16. To ensure safe upkeep of all the Testing Specifications. Any changes required in the specifications are to be made with the approval of Managing Director.
17. To ensure that under no circumstances the quality of our products deteriorates and no substandard product is released at all.
18. Establish & monitor product, process, equipment & cleaning validation system, calibration of analytical instruments implementation in plant.
19. Review of suitability of manufacturing all validation documents including analytical method validation procedure.
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