Quality Assurance - Manager

1.Establishment, Implementation and Maintenance of Quality system.

2.Approval of Standard Operating Procedures, Master Batch Manufacturing and Master Batch Packing Records.

3. Authorization of written procedures and other documents including amendments like Master Formula Records, Raw Material specifications, Packing Material specifications, Product specifications & General Analytical Specifications.

4. Monitoring of Compliance with GMP requirements.

5. Review and approval of change control, deviations, Risk assessment, Corrective action Preventive actions and other Quality management system related documents.

6. Inspection, investigation and taking of samples in order to monitor factor that may effect product quality.

7. Organizing Vendor Audit, Approval of new vendor & Vendor Evaluation.

8. Handling of regulatory audits

9. Review and approval of Process validation, cleaning validation, Water validation, HVAC Qualification & other Qualification & validation protocols & reports distribution.

10. Provide training related to GMP including the application and principles of Quality assurance

11. To Comply with the company policies, procedures and quality standards.

Co-ordinate with production, quality control, maintenance and stores department for Improving various quality concerned aspects.

12. Review all Quality assurance systems & Regulatory requirements for their current status on regular basis.

13. Responsible for ensuring the quality management system is implemented and maintained in accordance with ISO 9001:2008 requirements & that quality matters are resolved by those holding the relevant responsibility to do so.

14. Preparation of all regulatory documents related to licence application, WHO-GMP certificate and renewal of Licences and GMP certificates.

15. Ensure the regulatory documents like tender applications, performance certificate, general GMP certificate, Production certificate, No conviction certificate, Manufacturing and marketing certificate, etc as per the requirements.

16. Authorization of Reprocess / Rework procedures.

17. Any other responsibility as delegated by Management time to time.