Acme Generics Pvt Ltd, Baddi looking for Quality Assurance Head OSD

Acme Generics Pvt Ltd, Baddi looking for Quality Assurance Head OSD

8 April, 2022

JD and Specifications:

Designation: DGM/GM
Experience: Minimum 15 Years

Sub Line: Quality Assurance Head -OSD

Job Description:
Exposure to Regulatory Audits like USFDA / MHRA UK/ EU GMP will be preferred

1. To ensure cGMP Compliance in the plant.
2. To review and approve all departments Standard operating Procedure.
3. To ensure for the compliance of all Standard operating Procedure.
4. Strategic Planning & execution of Quality Management System.
5. To ensure the compliance of Quality Management system as per the requirement.
6. Responsible for leading the external audit & providing the compliance in timely manner.
7. To review and approve the Site Manager File (SMF),Validation Master Plan(VMP) and Quality manual.
8. Responsible for the approval and release of the Batch.
9. To review & approve specifications, Standard Test Procedure (STP) and General Test Procedure (GTP) of Quality Control Department.
10. Responsible for Self Inspection or Internal Audit and its compliance.
11. To review and approve all Validation and Qualification Protocols and Reports.
12. To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
13. To perform laundry audits in coordination with HR department.
14. To impart training on different topics including cGMP and GDP etc.
15. To coordinate during technology transfer of products to the sites.
16. To ensure that products are manufactured as per approved procedure.
17. Responsible for the investigation of the market complaints, Product recall & its compliances.
18. Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.
19. To provide the compliance reports of audits.
20. To give the final approval for Art Works.
21. To conduct interview and recruitments of Quality Assurance Personnel.
22. To ensure the Qualification and Re-qualification of the Equipment ,Facility and System
23. Responsible for review and approval of Stability Protocol and report.
24. To ensure work discipline in the department.
25. Responsible for quality agreement and its compliance.
26. To review and approve all apex documents

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