1.??????????確保在分析方法的開(kāi)發(fā)、確認(rèn)與驗(yàn)證、以及執(zhí)行過(guò)程中的合規(guī),滿足中國(guó)藥監(jiān)局相關(guān)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(dǎo)下,全面管理整個(gè)項(xiàng)目的質(zhì)量研究工作。Under?the?supervision?of?line?manager,?to????manage?quality?research?work?of?whole?project.?
?3.??????????作為項(xiàng)目分析負(fù)責(zé)人,與工藝開(kāi)發(fā)團(tuán)隊(duì)合作,分析方法的開(kāi)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(shè)計(jì)方案并進(jìn)行分析方法的轉(zhuǎn)移、確認(rèn)與驗(yàn)證,包括文檔工作(方案、批記錄、報(bào)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(zhǎng),培訓(xùn)、指導(dǎo)和管理小組分析研究員的日常工作,實(shí)現(xiàn)各項(xiàng)目目標(biāo)。As?group?leader,?to?train,?monitor?and????manage?analytical?scientists?in?regular?work?to?achieve?project?targets.?
?6.??????????負(fù)責(zé)相關(guān)的變更與偏差管理To?be?responsible?for?related?change?control?and????deviation?management.?
?7.??????????對(duì)分析儀器的日常管理與維護(hù)?Regular?operation?and?maintenance?of?analytical????instruments.?
?教育背景????Education?Requirements????????????大學(xué)本科或以上學(xué)歷,分析化學(xué)、化學(xué)、藥學(xué)等相關(guān)專業(yè),本科至少5年,碩士至少3年以上的分析相關(guān)工作經(jīng)驗(yàn)????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(lè)于學(xué)習(xí);團(tuán)隊(duì)合作,服務(wù)意識(shí)Work?with?passion.?Tend?to?learn?for????self-improvement.?Be?team????player?with?service?consciousness.?
?2.???????熟悉中國(guó)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(yǔ)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(qiáng)的分析方法開(kāi)發(fā)能力。Master?with?HPLC????and?GC?operation,?and?be?strong?in?analytical?method?development.