Assistant Manager Quality Assurance

Pregna International Ltd.

Job description

Key Responsibilities of Candidate:

1. Approve or reject, inputs, intermediate products, and finished products

2. Ensure that all tests and determinations established are performed

3. Ensure the evaluation of dossiers of manufacture of each product batch before release

4. Approve specifications, sampling instructions, test methods, and analytical determinations

5. Ensure that the analysis carried out by contract is reliable

6. Reviewing completed batch production and laboratory control record of critical process steps before releasing of Batch

7. Ensure that critical deviations are investigated and resolved

8. Ensure validation of analytical methods are conducted, studies of the suitability of pharmacopeia methods, equipment qualification, and calibration of analytical instruments

9. Review and Approve Validation protocols and reports

10. Ensure that quality-related complaints are investigated and resolved

11. To perform product quality review

12. To review and approve Quality Manual

13. To represent and lead the team during audits

14. Conduct job-related training for subordinates and ensure the documentation & job description. To contribute in meeting the quality standards by ensuring that all tests and analyses of samples are carried out in time to meet the laid down specifications and meet the customers requirement. cGMP and regulatory requirements are fully implemented

15. To review & approve all specs, test methods, SOPs, MFR, BMR, SMF, etc

16. To make sure that critical deviation, change control & customer complaint are investigated, addressed, and closed accordingly with necessary corrective & preventive action

17. Conduct Vendor Audit

18. To prepare compliance reports for external audits in coordination with different departments

19. To review and approve the qualification protocols and reports (DQ, IQ, OQ, and PQ)

20. To inform customers /Regulatory agencies in case of any major process change

21. Establish and maintain the policy for the do

Experience : 12 - 15 Years

No. of Openings : 1

Education : M.Pharma, M.Sc

Role : Quality Manager

Industry Type : Manufacturing / Production / Quality

Gender : Male

Job Country : India