職位描述
Expected Areas of Responsibilities 工作職責：
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要求對生產區域各工段進行工作，確保日常操作符合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.
按取樣手冊要求對產品中間體/成品進行取樣，并及時送樣在LIMS系統中輸入樣品數據
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.
對質量事件進行調查以確認事件根源，并完成調查報告采取適當的整改措施（CAPA）并跟蹤 其及時完成
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.
對顧客抱怨進行調查，并完成調查報告采取適當的整改措施（CAPA）并跟蹤其及時完成
5. Participate and monitor the validation of the manufacture process and facilities cleaning, and sample the products by the requirement of validation
參與產品生產過程及設備清潔驗證，監督驗證過程并按驗證要求取樣
6. Establish the relevant SOPs according to the requirements of cGMP and actual operations, to ensure the operations comply with SOPs.
根據GMP要求和實際日常工作情況制定相關SOP，確保操作與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
生產過程中物料、中間體的狀態控制并在SAP系統中查 詢 、核對及修改物 料 狀 態
8. Perform the sampling of environment and water system in production area according to the sampling method and frequency in SOP.
按照SOP規定的操作方法及取樣頻率對生產區域的環境及水系統進行取樣
9. Check PO and BOM to make sure the veracity
檢查生產指令單及BOM以確保其準確無誤
10. Complete other assignments given by the superior
完成領導交辦的其它任務
Skills & Ability Desired 必要的技能和能力 ：
1. Ability to use MS Office
具備使用辦公室軟件的能力
2. Ability of effective communication
具備有效溝通的能力
3. Ability of logical thinking
具備良好的邏輯思維的能力
4. Ability of problem solving
具備解決問題的能力
Experiences Desired相關工作經驗要求：
1.2 years or above work experience in quality unit of pharmaceutical company
兩年以上制藥行業質量部門工作經驗
2.Familiar with government regulation regarding to GMP and pharmaceutical technical process.
熟悉GMP和制藥工藝
