Assistant Manager Quality Assurance

Job descriptionKey Responsibilities of Candidate:1. Approve or reject, inputs, intermediate products, and finished products2. Ensure that all tests and determinations established are performed3. Ensure the evaluation of dossiers of manufacture of each product batch before release4. Approve specifications, sampling instructions, test methods, and analytical determinations5. Ensure that the analysis carried out by contract is reliable6. Reviewing completed batch production and laboratory control record of critical process steps before releasing of Batch7. Ensure that critical deviations are investigated and resolved8. Ensure validation of analytical methods are conducted, studies of the suitability of pharmacopeia methods, equipment qualification, and calibration of analytical instruments9. Review and Approve Validation protocols and reports10. Ensure that quality-related complaints are investigated and resolved11. To perform product quality review12. To review and approve Quality Manual13. To represent and lead the team during audits14. 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 customer’s requirement. cGMP and regulatory requirements are fully implemented15. To review & approve all specs, test methods, SOPs, MFR, BMR, SMF, etc16. To make sure that critical deviation, change control & customer complaint are investigated, addressed, and closed accordingly with necessary corrective & preventive action17. Conduct Vendor Audit18. To prepare compliance reports for external audits in coordination with different departments19. 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 change21. Establish and maintain the policy for the do

• Experience

  12 - 15 Years

• No. of Openings

  1

• Education

  Post Graduate (M.Pharma, M.Sc)

• Role

  Quality Manager

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office