Quality Assurance – Manager Officer

Job content

Department :- Quality Assurance

Qualification :- M.Pharm / B.Pharm / M.Sc / B.Sc

Age :- 30 To 40 Years

Experience :- Minimum 5 to 8 years of experience in the relevant position.

Job Location :- North Goa

Job Profile for QA Manager

1. To develop and implement Quality Assurance Strategies and Regulations.

2. Assess potential risks, ensure compliance and gives recommendations.

3. Facilitate audits, self inspections and regulatory inspections.

4. Liaison with external vendors, contractors or suppliers to ensure that their products or services meet the organizations quality standards.

5. Co-ordinate quality trainings.

6. Assign and manage review of batch records and all associated documentation including validations, procedures, protocols and investigations.

7. Assign and manage review of all stability data with inputs from R & D.

8. Review and approve product and process investigations in conjunction with Manufacturing and other Technical Personnel as required, ensuring that root cause analysis is completed.

9. Review and approval or written procedures / forms, etc

10. Handling of Complaints.

11. Handling of recalls.

12. CAPA, Non-Conforming Materials, Quality Events, Change Controls and Deviations.

13. Document Control.

14. Final Quality Record Review, Record retention and storage.

15. Final release of product.

16. Identify and support continuous improvement initiatives.

17. Review and update standard operating procedures.

18. Execute any other duties as may be entrusted by the Management from time to time.

Job Profile for QA Officer

1. Preparation of SOPs and other QA related documents.

2. Control of documents.

3. Periodic review and revision of documents such as SOP’s, etc.

4. Preparation of BMR’s/ BPR’s/ MFR’s/ Validation, protocols and reports.

5. In process quality checks.

6. Participation in process validation/ Packing validation.

7. Management of change control and deviation control activities.

8. Review of BMR and BPR before final release of Finished Goods.

9. Participation in self inspection.

10. Participation in complaint handling.

11. Annual product reviews.

12. Line clearances wherever required.

13. Coordinating with HRD to ensure training topics have been covered and documented.

14. Issue of BMR/ BPR/ MFR and other QA related documents.

15. Training schedules for shop floor employees and supervisors.

16. Training given to the shop floor employees along with supervisor wherever it is required.

17. Coordinating with other departments and complete the documentation part which is related to audit purpose eg. ISO, WHO, etc.

18. Review and update standard operating procedures and other QA related documents.

19. Execute any other duties and responsibilities as may be entrusted by the management from time to time.