1.負(fu)(fu)(fu)責QC管(guan)(guan)(guan)理(li)(li)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。2.負(fu)(fu)(fu)責審核原輔(fu)料(liao).包裝材料(liao).中間產品.成(cheng)品質(zhi)量標準(zhun),確(que)(que)保符合注冊標準(zhun)。3.對質(zhi)量標準(zhun).取(qu)樣方(fang)(fang)法.檢驗(yan)(yan)方(fang)(fang)法和(he)其(qi)他質(zhi)量管(guan)(guan)(guan)理(li)(li)的(de)文(wen)件及(ji)記錄(lu)進行(xing)(xing)審核。4.負(fu)(fu)(fu)責組(zu)織產品的(de)持續穩定性考(kao)(kao)察(cha)(cha)計(ji)劃并(bing)組(zu)織實施,審核穩定性考(kao)(kao)察(cha)(cha)方(fang)(fang)案和(he)報告。5.負(fu)(fu)(fu)責組(zu)織質(zhi)量控制(QC)配合研發部進行(xing)(xing)產品的(de)檢測方(fang)(fang)法轉移。6.負(fu)(fu)(fu)責組(zu)織實驗(yan)(yan)室(shi)設施設備(bei)管(guan)(guan)(guan)理(li)(li)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo),確(que)(que)保其(qi)正(zheng)常運行(xing)(xing)。7.負(fu)(fu)(fu)責組(zu)織實驗(yan)(yan)室(shi)檢驗(yan)(yan)試劑.試液.對照品.菌(jun)種(zhong).培養基等管(guan)(guan)(guan)理(li)(li)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo),確(que)(que)保實驗(yan)(yan)正(zheng)常進行(xing)(xing)。8.負(fu)(fu)(fu)責組(zu)織實驗(yan)(yan)室(shi)文(wen)件管(guan)(guan)(guan)理(li)(li)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo),包括文(wen)件起草.修(xiu)訂.撤銷等,并(bing)審核。9.參與(yu)質(zhi)量事故的(de)調查工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。10.參與(yu)GMP自檢工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)11.參與(yu)物料(liao)供(gong)應(ying)商評估工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。12.參與(yu)外部審計(ji).委(wei)托(tuo)生(sheng)產.委(wei)托(tuo)檢驗(yan)(yan)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo),參與(yu)整改措施的(de)制訂工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。13.負(fu)(fu)(fu)責實驗(yan)(yan)室(shi)安(an)全管(guan)(guan)(guan)理(li)(li)工(gong)(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。
本科及以上(shang)(shang)學(xue)歷,制藥(yao)工(gong)程、藥(yao)物分析、化(hua)學(xue)分析等相關專業,有4年以上(shang)(shang)相關崗(gang)位工(gong)作(zuo)經驗。
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