Qlty Assurance Methods
1. Perform the routine inspections on the key steps in production area according to the SOPs, to ensure the routine operations comply with the requirements of SOP, GMP and MLS/PLS
2. Sample the intermediate bulk or finished product according to Sampling Manual, and send it to QC. Enter the sample data in LIMS system.
3. Fully investigate the quality event to find the root cause and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA.
4. Investigate customer complaint and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA.
5. Participate and monitor the validation of the manufacture process and facilities cleaning, and sample the products by the requirement of validation
6. Establish the relevant SOPs according to the requirements of cGMP and actual operations, to ensure the operations comply with SOPs.
7. Control the status of the raw materials and intermediate bulks used for production. And inquire, re-check and change the status of some raw materials and packaging materials in SAP system
生产过程中物料、中间体的状态控制并在SAP系统中查 询 、核对及修改物 料 状 态
8. Perform the sampling of environment and water system in production area according to the sampling method and frequency in SOP.
9. Check PO and BOM to make sure the veracity
10. Complete other assignments given by the superior