Sr. Officer (QA)

Job Description

1. To review URS, DQ of new equipment, system & utilities like HVAC, Water system, Compressed air, Nitrogen system etc. 2. To prepare, monitor and review of qualification documents i.e. FAT, SAT, IQ, OQ & PQ protocol and reports. 3. To review all types of area layouts. 4. To execute the facility qualification for release facility in routine use. 5. To review calibration certificate of instruments. 6. To review preventive maintenance report. 7. To prepare, monitor and review temperature mapping protocol and report of equipment and area. 8. To tracking of periodic qualification of equipment, area and inform to responsible person. 9. Prepare & review of Standard Operating Procedure. 10. Preparation & review of Quality risk assessments report. 11. Preparation of Product Quality Review Report. 12. Preparation & review of Trend report of Deviation, Market Complaint, Out of Specification, Out of trend, Return Goods. 13. Release of RM/PM/FP & Intermediates in SAP system. 14. Perform internal audits of different departments. 15. Knowledge about GEMBA walk / Walk through audit in respective department and ensure the compliance of identified observations. 16. Initiation, review, evaluation & closure of change controls as initiator or QA coordinator role. 17. Issuance, archival and control of all documents likes SOPs, MPCR, format and logbook. 18. Withdrawal of raw material, intermediate/ finished product, stability, hold time and equipment cleaning (swab) samples.