Executive - QA Documentation

Role & responsibilities

1. Primarily Responsible for Vendor Qualification and Vendor Approval accordingly and compilation of documents.

2. Handling of Issuance and Retrieval of batch number, batch manufacturing record, batch packing record, Register, Logbooks, SOPs, Formats, worksheets protocols, Analytical protocols of all departments.

3. Preparation, Review and compilation of the Annual Product Quality Review.

4. To prepare and review of quality and other departments SOPs.

5. Responsible for preparation and up-dation of quality assurance SOPs.

6. Responsible for preparation and up-dation of SOP’s Index of all the departments.

7. To handle and maintain specimen signature, job description etc.

8. To support the practice of documentation and data control.

9. To review the Analytical records, Batch manufacturing records and Batch packing records.

10. To identify and reporting of any non-conformance or any discrepancy related to manufacturing, packing and warehouse.

11. Preparation, planning, coordination and execution of Annual Training Program, assessment and handling of training records of all departments and to monitor/ Supervision and control over the workman in their designated premises at the site.

12. To ensure maintenance of environmental conditions (Relative Humidity, Temperature and Differential pressure) in respective areas.

13. Ensure to implementation of cGMP, GDP and Data Integrity in Plant Premises.

14. To handle the artworks approval, shade cards and other packing material.

15. To handle the preparation of material code in SAP & up-dation of BOM in SAP.

Preferred candidate profile

Qualification: B. Pharma/ M. Pharma

Experience: 3 to 7 Years