Job
Description
Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time
