职位描述
Expected Areas of Responsibilities 工作职责：
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
Skills & Ability Desired 必要的技能和能力 ：
1. Ability to use MS Office
具备使用办公室软件的能力
2. Ability of effective communication
具备有效沟通的能力
3. Ability of logical thinking
具备良好的逻辑思维的能力
4. Ability of problem solving
具备解决问题的能力
Experiences Desired相关工作经验要求：
1.2 years or above work experience in quality unit of pharmaceutical company
两年以上制药行业质量部门工作经验
2.Familiar with government regulation regarding to GMP and pharmaceutical technical process.
熟悉GMP和制药工艺
