Role & responsibilities 1. Handling and monitoring of process validation/ cleaning validation plan and procedure.2. Monitoring of Preventive Maintenance / Internal calibration and External calibration.3. Review of calibration / validation / qualification documentation.4. To investigate the market complaints, OOS (out of specification), OOT (out of trend), Deviation,Change control, Lab-incident, non-conformance, product recall, reprocess, online rejection, returnetc. and to suggest and implement methods to avoid reoccurrence.5. To verify URS, DQ, FAT, IQ, OQ, PQ and Requalification of the Equipments/Instruments of allsupporting system/area.6. To identify Corrective and Preventive Actions and ensure timely tracking and implementation of the same.7. To monitor in process testing and release/reject of in process material as well as finish product.8. Report all malfunctions to production executives to ensure immediate action.9. Review current standards and policies.10. Review of investigation with risk assessment & root cause analysis and impact assessment.11. Keep records of quality reports, statistical reviews and relevant documentation.12.Ensure all legal standards are met.13. Ensure compliance with current Good Manufacturing Practice on the shop floor duringmanufacturing activities.14. Conduct the selfinspection and/or quality audit.15. Communicate with external quality assurance officers during on-site inspections.16. Any other work assigned by reporting manager/seniors diligently and promptly.