1.??????????確保在分析方法的開發(fā)、確認與驗證、以及執(zhí)行過程中的合規(guī)，滿足中國藥監(jiān)局相關法規(guī)要求及其他GMP法規(guī)要求Assure?in-compliance?in?analytical?development,??verification?and?validation,?and?execution,????according?to?NMPA?regulations?and?GMP?requirements.?
?2.??????????在經(jīng)理的指導下，全面管理整個項目的質量研究工作。Under?the?supervision?of?line?manager,?to????manage?quality?research?work?of?whole?project.?
?3.??????????作為項目分析負責人，與工藝開發(fā)團隊合作，分析方法的開發(fā)、并一起制定控制策略As?analytical?project?leader?,?to?develop????analytical?methods?to?support?process?development,?and?to?define?the?control????strategy.?
?4.??????????能夠設計方案并進行分析方法的轉移、確認與驗證，包括文檔工作（方案、批記錄、報告）和執(zhí)行?Design?the?protocol?and?implement????the?transfer,?verification?and?validation?of?analytical?methods,?including????both?good?documentation?(protocols,?analytical?batch?record,?reports)?and????execution?of?lab?work.?
?5.??????????作為組長，培訓、指導和管理小組分析研究員的日常工作，實現(xiàn)各項目目標。As?group?leader,?to?train,?monitor?and????manage?analytical?scientists?in?regular?work?to?achieve?project?targets.?
?6.??????????負責相關的變更與偏差管理To?be?responsible?for?related?change?control?and????deviation?management.?
?7.??????????對分析儀器的日常管理與維護?Regular?operation?and?maintenance?of?analytical????instruments.?
?教育背景????Education?Requirements????????????大學本科或以上學歷，分析化學、化學、藥學等相關專業(yè)，本科至少5年，碩士至少3年以上的分析相關工作經(jīng)驗????BS?or?above?in?Analytical?Chemistry,?Chemistry?or????Pharmaceutical?Chemistry?with?5+?years?????for?BS?or?3+?years?for?MS?of?working?experience.?
?其他需求????Other?Requirements????????????1.???????積極向上，樂于學習；團隊合作，服務意識Work?with?passion.?Tend?to?learn?for????self-improvement.?Be?team????player?with?service?consciousness.?
?2.???????熟悉中國藥典、USP、歐洲藥典，及ICH,?FDA,?EMA法規(guī)要求Be?familiar?with????Ch.?P,?USP,?Ph.Eur.?,?and?ICH,?FDA,?EMA?regulatory?requirements.?
?3.???????良好的英語書寫交流能力Good?writing?and????communication?skills?in?English.?
?4.??????????精通HPLC和GC操作，并具備很強的分析方法開發(fā)能力。Master?with?HPLC????and?GC?operation,?and?be?strong?in?analytical?method?development.
