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1.負(fu)(fu)責(ze)(ze)QC管(guan)理(li)工(gong)作。2.負(fu)(fu)責(ze)(ze)審核(he)原(yuan)輔料.包裝材料.中間產品(pin).成(cheng)品(pin)質(zhi)量(liang)(liang)標(biao)準(zhun)(zhun)，確保(bao)符合(he)注(zhu)冊標(biao)準(zhun)(zhun)。3.對(dui)質(zhi)量(liang)(liang)標(biao)準(zhun)(zhun).取樣方(fang)(fang)法.檢(jian)驗(yan)(yan)(yan)方(fang)(fang)法和(he)其(qi)他質(zhi)量(liang)(liang)管(guan)理(li)的(de)(de)文(wen)件(jian)及記錄進行(xing)審核(he)。4.負(fu)(fu)責(ze)(ze)組織(zhi)(zhi)產品(pin)的(de)(de)持續(xu)穩(wen)(wen)定(ding)性考察計劃并組織(zhi)(zhi)實(shi)(shi)施(shi)(shi)，審核(he)穩(wen)(wen)定(ding)性考察方(fang)(fang)案和(he)報告。5.負(fu)(fu)責(ze)(ze)組織(zhi)(zhi)質(zhi)量(liang)(liang)控制(zhi)（QC）配合(he)研發(fa)部(bu)(bu)進行(xing)產品(pin)的(de)(de)檢(jian)測方(fang)(fang)法轉移(yi)。6.負(fu)(fu)責(ze)(ze)組織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)(yan)室(shi)設施(shi)(shi)設備管(guan)理(li)工(gong)作，確保(bao)其(qi)正常運行(xing)。7.負(fu)(fu)責(ze)(ze)組織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)(yan)室(shi)檢(jian)驗(yan)(yan)(yan)試劑(ji).試液.對(dui)照品(pin).菌種.培養基等管(guan)理(li)工(gong)作，確保(bao)實(shi)(shi)驗(yan)(yan)(yan)正常進行(xing)。8.負(fu)(fu)責(ze)(ze)組織(zhi)(zhi)實(shi)(shi)驗(yan)(yan)(yan)室(shi)文(wen)件(jian)管(guan)理(li)工(gong)作，包括文(wen)件(jian)起草.修訂(ding).撤銷(xiao)等，并審核(he)。9.參(can)與質(zhi)量(liang)(liang)事故的(de)(de)調(diao)查工(gong)作。10.參(can)與GMP自檢(jian)工(gong)作11.參(can)與物料供(gong)應商(shang)評估工(gong)作。12.參(can)與外部(bu)(bu)審計.委托(tuo)生產.委托(tuo)檢(jian)驗(yan)(yan)(yan)工(gong)作，參(can)與整改措施(shi)(shi)的(de)(de)制(zhi)訂(ding)工(gong)作。13.負(fu)(fu)責(ze)(ze)實(shi)(shi)驗(yan)(yan)(yan)室(shi)安全管(guan)理(li)工(gong)作。