QA Executive @ Pharma Unit

6 days ago

Ankleshwar, India U V Pharma Full time

1. To review the QA SOPs with the guideline requirements.

2. To release the product to customer in the absence of head QA.

3. To arrange for the preparation of the training schedule by coordinating with Production, Store/

Warehouse, QC dept. etc.

4. To prepare and review the annual product review.

5. To issue change control form, reviewing the change proposal, and maintain the logbook.

6. To maintain the log of deviation and assist in the investigation.

7. To assist the head in OOS and OOT investigation.

8. To follow-up for CAPA and maintain the register.

9. To participate the internal audits, Customer audit, Regulatory inspection.

10. To witness and verify process validation, cleaning validation and equipment qualification protocols

and reports.

11. Review of Analytical and Batch Manufacture Records for Batch Release.

12. To review the vendor documents and prepare the approved vendor list.

13. To cross check the pest control effectiveness through rounds.

14. To take plant rounds to verify the activities are carried as per approved procedure.

15. To attend the QR meeting as per schedule.

16. To train the operating personnel in documentation and data integrity as per procedure.

17. To cross checks the calibration and AHU validation activity.

18. To issue the Batch Manufacturing Record, Equipment Cleaning Record, Logbooks, Test data sheet,

Change Control form, Deviation form, OOS form, OOT form Customer Complaint form, as per the

request form from Respective department.

19. To Initiation and review of Stability Study.

20. Line Clearance during production activities (e.g. New equipment installation and cleaning, Cleaning

after product change over, packaging etc.).

21. Distribution, archival and control of the documents.

22. Ensuring compliance of the systems used for maintaining the equipments and calibrating

critical Equipment.

**Salary**: ₹400,000.00 - ₹500,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

**Experience**:

- total work: 4 years (required)

Work Location: In person

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