Junior Officer QA

Job Summary:

1. Responsible for compliance to IPQA activities at site.
2. Responsible to ensure that there is no delay in production activity.

Essential Job Functions:

1. Working in day & night shift
2. Perform internal calibration and monitoring any calibration of laboratory equipment in IPQA room as per schedule.
3. Monitoring environment control.
4. Authorize clearance for machine setting.
5. Authorize line clearance for production.
6. Approval of coding details.
7. Sample collection.
8. Enhance effectiveness of in process quality control in order to improve product quality and investigation on market complaint.
9. Ensure that all defects reported during in process checks have rectified, corrective actions taken and recorded.
10. Observation and highlighting activity non-compliance to GMP.
11. BPR inspection / reconciliation.
12. Verification of destruction of rejected/balances of packaging material in Production.
13. Responsible for issuance of forms to production.
14. Ensure online clearances of BPR timely and correctly
15. Ensure sufficient man power and also coverage during the working hours and weekend.
16. Ensure timely line clearances to production timely.
17. Ensure adherence to SOP, Manufacturing Instruction & Packaging Instruction 100%.
18. Ensure all in process control activity is performed as per regulated procedures and current GMP.
19. Enhance effectiveness of in process quality control in order to improve product quality.
20. Ensure sample collection made correctly as per the required quantity (finished product, control sample, stability sample, etc).
21. Perform TRF sampling activity in SAP HANA system.
22. Reconciler of EDMS forms.
23. Reconciler of batch record in BRMS system.