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1.負(fu)(fu)(fu)(fu)責QC管(guan)理(li)(li)工(gong)作。2.負(fu)(fu)(fu)(fu)責審(shen)(shen)核(he)原輔料(liao)(liao).包(bao)裝材料(liao)(liao).中間產品(pin).成品(pin)質量(liang)(liang)標準(zhun)，確(que)保(bao)符合(he)注冊標準(zhun)。3.對(dui)(dui)質量(liang)(liang)標準(zhun).取樣方(fang)(fang)法.檢(jian)(jian)驗(yan)(yan)方(fang)(fang)法和其(qi)(qi)他質量(liang)(liang)管(guan)理(li)(li)的(de)文(wen)(wen)件(jian)及記錄進(jin)(jin)行審(shen)(shen)核(he)。4.負(fu)(fu)(fu)(fu)責組(zu)織(zhi)(zhi)產品(pin)的(de)持續穩定性考察計劃并組(zu)織(zhi)(zhi)實(shi)(shi)施，審(shen)(shen)核(he)穩定性考察方(fang)(fang)案和報告(gao)。5.負(fu)(fu)(fu)(fu)責組(zu)織(zhi)(zhi)質量(liang)(liang)控制（QC）配合(he)研(yan)發(fa)部進(jin)(jin)行產品(pin)的(de)檢(jian)(jian)測方(fang)(fang)法轉移。6.負(fu)(fu)(fu)(fu)責組(zu)織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)室設施設備管(guan)理(li)(li)工(gong)作，確(que)保(bao)其(qi)(qi)正(zheng)常運行。7.負(fu)(fu)(fu)(fu)責組(zu)織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)室檢(jian)(jian)驗(yan)(yan)試(shi)劑.試(shi)液(ye).對(dui)(dui)照品(pin).菌種(zhong).培養基等(deng)管(guan)理(li)(li)工(gong)作，確(que)保(bao)實(shi)(shi)驗(yan)(yan)正(zheng)常進(jin)(jin)行。8.負(fu)(fu)(fu)(fu)責組(zu)織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)室文(wen)(wen)件(jian)管(guan)理(li)(li)工(gong)作，包(bao)括文(wen)(wen)件(jian)起草.修(xiu)訂.撤(che)銷(xiao)等(deng)，并審(shen)(shen)核(he)。9.參與質量(liang)(liang)事(shi)故的(de)調查工(gong)作。10.參與GMP自檢(jian)(jian)工(gong)作11.參與物料(liao)(liao)供(gong)應(ying)商評估工(gong)作。12.參與外部審(shen)(shen)計.委(wei)托生產.委(wei)托檢(jian)(jian)驗(yan)(yan)工(gong)作，參與整改(gai)措(cuo)施的(de)制訂工(gong)作。13.負(fu)(fu)(fu)(fu)責實(shi)(shi)驗(yan)(yan)室安全管(guan)理(li)(li)工(gong)作。