1.負責(ze)(ze)(ze)(ze)QC管理(li)(li)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)。2.負責(ze)(ze)(ze)(ze)審(shen)核原輔料.包(bao)裝材料.中間產品(pin)(pin).成(cheng)品(pin)(pin)質量(liang)標(biao)準,確(que)保符合注冊標(biao)準。3.對質量(liang)標(biao)準.取樣方(fang)法.檢(jian)驗(yan)(yan)(yan)方(fang)法和其他(ta)質量(liang)管理(li)(li)的文件及記錄進行審(shen)核。4.負責(ze)(ze)(ze)(ze)組(zu)織(zhi)(zhi)(zhi)產品(pin)(pin)的持(chi)續穩定(ding)性考(kao)察計(ji)劃并(bing)組(zu)織(zhi)(zhi)(zhi)實施,審(shen)核穩定(ding)性考(kao)察方(fang)案(an)和報告。5.負責(ze)(ze)(ze)(ze)組(zu)織(zhi)(zhi)(zhi)質量(liang)控(kong)制(QC)配合研發部進行產品(pin)(pin)的檢(jian)測方(fang)法轉移。6.負責(ze)(ze)(ze)(ze)組(zu)織(zhi)(zhi)(zhi)實驗(yan)(yan)(yan)室(shi)(shi)設施設備管理(li)(li)工(gong)(gong)(gong)作(zuo)(zuo)(zuo),確(que)保其正(zheng)常運行。7.負責(ze)(ze)(ze)(ze)組(zu)織(zhi)(zhi)(zhi)實驗(yan)(yan)(yan)室(shi)(shi)檢(jian)驗(yan)(yan)(yan)試(shi)(shi)劑.試(shi)(shi)液.對照品(pin)(pin).菌種(zhong).培養(yang)基等(deng)管理(li)(li)工(gong)(gong)(gong)作(zuo)(zuo)(zuo),確(que)保實驗(yan)(yan)(yan)正(zheng)常進行。8.負責(ze)(ze)(ze)(ze)組(zu)織(zhi)(zhi)(zhi)實驗(yan)(yan)(yan)室(shi)(shi)文件管理(li)(li)工(gong)(gong)(gong)作(zuo)(zuo)(zuo),包(bao)括文件起(qi)草.修訂.撤(che)銷等(deng),并(bing)審(shen)核。9.參與(yu)(yu)質量(liang)事(shi)故的調查工(gong)(gong)(gong)作(zuo)(zuo)(zuo)。10.參與(yu)(yu)GMP自檢(jian)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)11.參與(yu)(yu)物料供(gong)應商評估工(gong)(gong)(gong)作(zuo)(zuo)(zuo)。12.參與(yu)(yu)外部審(shen)計(ji).委托生產.委托檢(jian)驗(yan)(yan)(yan)工(gong)(gong)(gong)作(zuo)(zuo)(zuo),參與(yu)(yu)整改措施的制訂工(gong)(gong)(gong)作(zuo)(zuo)(zuo)。13.負責(ze)(ze)(ze)(ze)實驗(yan)(yan)(yan)室(shi)(shi)安全管理(li)(li)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)。
本科及(ji)以上學(xue)歷,制(zhi)藥(yao)工(gong)程(cheng)、藥(yao)物分析、化學(xue)分析等(deng)相(xiang)關專(zhuan)業,有4年以上相(xiang)關崗位(wei)工(gong)作經驗。
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