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1.負責(ze)(ze)(ze)QC管(guan)(guan)(guan)理(li)工(gong)(gong)(gong)作(zuo)(zuo)。2.負責(ze)(ze)(ze)審(shen)(shen)核原(yuan)輔料.包裝材料.中(zhong)間產品(pin)(pin)(pin).成品(pin)(pin)(pin)質(zhi)量(liang)標準(zhun)，確保(bao)符合注冊標準(zhun)。3.對質(zhi)量(liang)標準(zhun).取樣方法.檢(jian)驗(yan)(yan)(yan)方法和其他質(zhi)量(liang)管(guan)(guan)(guan)理(li)的(de)文件及記(ji)錄進行審(shen)(shen)核。4.負責(ze)(ze)(ze)組(zu)(zu)織(zhi)產品(pin)(pin)(pin)的(de)持(chi)續穩定性考(kao)察計劃(hua)并(bing)組(zu)(zu)織(zhi)實(shi)施，審(shen)(shen)核穩定性考(kao)察方案和報告(gao)。5.負責(ze)(ze)(ze)組(zu)(zu)織(zhi)質(zhi)量(liang)控制（QC）配合研發(fa)部進行產品(pin)(pin)(pin)的(de)檢(jian)測方法轉(zhuan)移。6.負責(ze)(ze)(ze)組(zu)(zu)織(zhi)實(shi)驗(yan)(yan)(yan)室設施設備管(guan)(guan)(guan)理(li)工(gong)(gong)(gong)作(zuo)(zuo)，確保(bao)其正(zheng)常運行。7.負責(ze)(ze)(ze)組(zu)(zu)織(zhi)實(shi)驗(yan)(yan)(yan)室檢(jian)驗(yan)(yan)(yan)試(shi)劑(ji).試(shi)液.對照(zhao)品(pin)(pin)(pin).菌種.培養基等(deng)管(guan)(guan)(guan)理(li)工(gong)(gong)(gong)作(zuo)(zuo)，確保(bao)實(shi)驗(yan)(yan)(yan)正(zheng)常進行。8.負責(ze)(ze)(ze)組(zu)(zu)織(zhi)實(shi)驗(yan)(yan)(yan)室文件管(guan)(guan)(guan)理(li)工(gong)(gong)(gong)作(zuo)(zuo)，包括文件起(qi)草(cao).修訂.撤銷等(deng)，并(bing)審(shen)(shen)核。9.參與(yu)質(zhi)量(liang)事故的(de)調查工(gong)(gong)(gong)作(zuo)(zuo)。10.參與(yu)GMP自(zi)檢(jian)工(gong)(gong)(gong)作(zuo)(zuo)11.參與(yu)物料供應商評(ping)估工(gong)(gong)(gong)作(zuo)(zuo)。12.參與(yu)外部審(shen)(shen)計.委(wei)(wei)托生產.委(wei)(wei)托檢(jian)驗(yan)(yan)(yan)工(gong)(gong)(gong)作(zuo)(zuo)，參與(yu)整(zheng)改(gai)措施的(de)制訂工(gong)(gong)(gong)作(zuo)(zuo)。13.負責(ze)(ze)(ze)實(shi)驗(yan)(yan)(yan)室安(an)全管(guan)(guan)(guan)理(li)工(gong)(gong)(gong)作(zuo)(zuo)。