QA inspector

Qlty Assurance Methods

Posted 34 days ago Full_time R1515393

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
   按SOP要求对生产区域各工段进行工作,确保日常操作符合SOP 、GMP及MLS/PLS的要求
2. Sample the intermediate bulk or finished product according to Sampling Manual, and send it to QC.  Enter the sample data in LIMS system.
   按取样手册要求对产品中间体/成品进行取样,并及时送样在LIMS系统中输入样品数据
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.
   对质量事件进行调查以确认事件根源,并完成调查报告采取适当的整改措施(CAPA)并跟踪 其及时完成
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.
   对顾客抱怨进行调查,并完成调查报告采取适当的整改措施(CAPA)并跟踪其及时完成
5. Participate  and monitor  the validation of the  manufacture process and facilities cleaning, and sample the products by the requirement of validation
   参与产品生产过程及设备清洁验证,监督验证过程并按验证要求取样
6. Establish the relevant SOPs according to the requirements of cGMP and actual operations, to ensure the operations comply with SOPs.
   根据GMP要求和实际日常工作情况制定相关SOP,确保操作与SOP一致
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.
   按照SOP规定的操作方法及取样频率对生产区域的环境及水系统进行取样
9. Check PO and BOM to make sure the veracity
   检查生产指令单及BOM以确保其准确无误
10. Complete other assignments given by the superior
   完成领导交办的其它任务