崗位職責
Responsible for the check in line clearance of production, material status, reprocessing, and packaging stages and other critical steps or aspects which may influence the quality of products.
負責檢查生產清場、物料狀態、返工、包裝和其他可能影響產品質量的步驟;
Responsible for shop floor quality monitoring, sampling and relevant works, make sure all the products produced in Zhongshan site compliance with GMP.
負責現場質量監控、取樣和相關工作,確保所有中山工廠生產的產品符合GMP要求;
Responsible for the checking and qualifying of the equipment maintain, process and materials change.
負責檢查和確認設備維修、工藝和物料的變更情況收集;
Responsible for the environmental monitoring and water system monitoring.
負責環境監控和水系統監控;
Responsible for checking on the disposal materials and monitor the destroying operation.
負責不合格物料的檢查和監控銷毀;
Participate in any quality related issue investigation and evaluation.
參與質量相關事件的調查和評估;
BPR collecting and first review.
批記錄的收集整理和初審。
任職要求
Education教育 : Graduate from pharmacy or relevant specialties above junior college.
必須是藥學或相關專業大專以上的學歷;
Languages語言: Mastering certain computer operating and professional English, and could finish task satisfactorily which refer to them.
具有一定的電腦操作水平和專業英語水平,能很好的完成工作中涉及的這兩方面的工作。
Experience經驗: Obtained proper training on pharmaceutical quality management, and with more than one year’s relevant working experience.
有較好的藥品質量管理培訓和一年以上相關工作經驗;
Familiar with items of GMP, can comply with requirements of GMP and relevant SOP strictly, and could judge and handle correctly common questions.
熟悉GMP條款,并能嚴格的遵守GMP要求和執行相關的SOP,對藥品生產和質量管理中的一般問題能夠做出正確的判斷和處理;
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