QA Executive

5 days ago


Boisar Thane Maharashtra, India Vision Enterprises Full time

**QA Executive **required in Pharma Formulation Industry.

Industry Background : Pharmaceutical (Liquid Products)

**Position : QA Executive.**

Qualification: MSC/BSC in Chemistry / B Pharma

Experience: 5-8 years

Location: Boisar, Tarapur

Gender: Male/Female

CTC: 5 to 6 Lakhs.

Contact Person: Ajinkya Pardeshi

Contact No-91686203491.

Job Profile:

- 1.Assigning work allocation to the team member as per production planning

2. Prepare MFR with the help of TTD received from RND Dept.

3. Prepare BMR & BPR as per production planning requirement

4. Prepare HVAC calibration and Qualification protocol

5. Preparation and compilation verification of process validation protocols and records

6. Preparation and compilation verification of cleaning validation protocols and records

7. Preparation and compilation verification of Hold time study validation protocols and records

8. Preparation of Qualification / Validation protocol of the Equipment, Systems and process by co-ordination with Production & Engineering Department

9. Ensure the issuance of required documents and samples to Regulatory, CQA and Purchase Dept. as per requirement.

10. Ensure the preparation, revision/review of revised documents (SOP’s, Specification and Protocol) and retrieval of obsolete documents.

11. Investigate the cause of any non-conformance and its corrective / preventive action.

12. Ensure the Analytical method validation of cleaning process before conducting cleaning validation.

13. Cleaning Validation Analytical Data collection and summary report preparation of cleaning validation.

14. Plan and execute process validity activity at the defined frequency

15. Preparation of Audit compliance report within specified period

16. Ensure effective CAPA management system for Internal and external audit compliances.

17. Responsible to evaluate investigation of market complaint with effective implementation of CAPA.

18. Responsible for verification SMF, VMP, PQR and Quality Manual

19. Carryout SAP usage decision to release raw material, packing material, semi finished goods and finished goods as and when require.

20. Carryout SAP process order release for assigning Batch number to semi finished and finished product.

21. Preparation of SAP inspection plan for pre-shipment of finished products

**Salary**: ₹500,000.00 - ₹600,000.00 per month


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