職位描述
職位描述：
Expected Areas of Responsibilities 工作職責(zé)：
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(duì)生產(chǎn)區(qū)域各工段進(jìn)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(cè)要求對(duì)產(chǎn)品中間體/成品進(jìn)行取樣，并及時(shí)送樣在LIMS系統(tǒng)中輸入樣品數(shù)據(jù)
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(duì)質(zhì)量事件進(jìn)行調(diào)查以確認(rèn)事件根源，并完成調(diào)查報(bào)告采取適當(dāng)?shù)恼拇胧–APA）并跟蹤 其及時(shí)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(duì)顧客抱怨進(jìn)行調(diào)查，并完成調(diào)查報(bào)告采取適當(dāng)?shù)恼拇胧–APA）并跟蹤其及時(shí)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(chǎn)品生產(chǎn)過(guò)程及設(shè)備清潔驗(yàn)證，監(jiān)督驗(yàn)證過(guò)程并按驗(yàn)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(jù)GMP要求和實(shí)際日常工作情況制定相關(guān)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(chǎn)過(guò)程中物料、中間體的狀態(tài)控制并在SAP系統(tǒng)中查 詢 、核對(duì)及修改物 料 狀 態(tài)
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(guī)定的操作方法及取樣頻率對(duì)生產(chǎn)區(qū)域的環(huán)境及水系統(tǒng)進(jìn)行取樣
9. Check PO and BOM to make sure the veracity
檢查生產(chǎn)指令單及BOM以確保其準(zhǔn)確無(wú)誤
10. Complete other assignments given by the superior
完成領(lǐng)導(dǎo)交辦的其它任務(wù)
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(wèn)題的能力
Experiences Desired相關(guān)工作經(jīng)驗(yàn)要求：
1.2 years or above work experience in quality unit of pharmaceutical company
兩年以上制藥行業(yè)質(zhì)量部門(mén)工作經(jīng)驗(yàn)
2.Familiar with government regulation regarding to GMP and pharmaceutical technical process.
熟悉GMP和制藥工藝
