Deputy Manager Quality

Kreative Organics Private Limited

1. Ensure easy traceability of document/form/SOPs/log books etc issuance and retrieve as per approved written procedures.

2. Review and approve procedure and records of raw materials, intermediates, packaging and labelling materials.

3. Review and approve completed batch production and laboratory control records before release of saleable intermediates and API for distribution.

4. Review and approve of annual product quality review and applicable QMS tracking reports (Change management, deviation management and CAPA management etc.)

5. Providing training to cross functional team members on cGMP procedure and revised standard operating procedure, protocols where applicable.

6. Handling of QMS documents such as deviations, out of specifications, complaints, returned goods, change controls, incidents, recalls, vendor qualification and CAPA.

7. Review & Approve validation protocols and preparations of reports as applicable.

8. Ensure that all applicable CAPAs are implemented and effective.

9. Approve all specifications and master production instructions.

10. Verify the maintenance and calibration data critical equipments as per approved procedure.

11. Review and approve stability protocols and reports of API and/or intermediates as applicable

12. Delegate applicable QMS activities to immediate sub-ordinates on need basis.

13. Participate in self-inspection, other customer/regulatory inspections

14. Approve all procedure impacting the quality of intermediate or APIs; production and control operations are clearly specified in written procedure and adopt GMP requirement.

15. Approving raw material, intermediate & API contract manufacturer if applicable as per vendor qualification procedure.

16. Review and approve of risk assessments reports for product & other risk assessment.

17. Review and approve of equipment and other qualification documents.

18. Responsible for the vendor auditing (Vendor, Supplier and External labs) preparing report & review and approve of audit co

Experience : 9 - 13 Years

No. of Openings : 2

Role : Deputy Manager Quality

Industry Type : Manufacturing / Production / Quality

Gender : Male

Job Country : India