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1.負(fu)責(ze)QC管(guan)(guan)(guan)理(li)(li)工(gong)(gong)作(zuo)。2.負(fu)責(ze)審(shen)(shen)(shen)核原(yuan)輔料(liao).包裝材(cai)料(liao).中間產品.成(cheng)品質(zhi)(zhi)量(liang)標準，確保(bao)符合(he)注冊標準。3.對質(zhi)(zhi)量(liang)標準.取樣方(fang)(fang)法(fa).檢驗方(fang)(fang)法(fa)和(he)其(qi)他質(zhi)(zhi)量(liang)管(guan)(guan)(guan)理(li)(li)的(de)文(wen)(wen)件及記錄(lu)進行(xing)審(shen)(shen)(shen)核。4.負(fu)責(ze)組(zu)織(zhi)(zhi)產品的(de)持續穩定性(xing)考察計劃并組(zu)織(zhi)(zhi)實施，審(shen)(shen)(shen)核穩定性(xing)考察方(fang)(fang)案和(he)報(bao)告。5.負(fu)責(ze)組(zu)織(zhi)(zhi)質(zhi)(zhi)量(liang)控(kong)制(zhi)（QC）配合(he)研發(fa)部進行(xing)產品的(de)檢測方(fang)(fang)法(fa)轉移。6.負(fu)責(ze)組(zu)織(zhi)(zhi)實驗室設(she)施設(she)備管(guan)(guan)(guan)理(li)(li)工(gong)(gong)作(zuo)，確保(bao)其(qi)正常(chang)運行(xing)。7.負(fu)責(ze)組(zu)織(zhi)(zhi)實驗室檢驗試(shi)劑.試(shi)液.對照品.菌(jun)種(zhong).培養基等管(guan)(guan)(guan)理(li)(li)工(gong)(gong)作(zuo)，確保(bao)實驗正常(chang)進行(xing)。8.負(fu)責(ze)組(zu)織(zhi)(zhi)實驗室文(wen)(wen)件管(guan)(guan)(guan)理(li)(li)工(gong)(gong)作(zuo)，包括文(wen)(wen)件起草(cao).修訂.撤銷等，并審(shen)(shen)(shen)核。9.參與質(zhi)(zhi)量(liang)事故的(de)調查工(gong)(gong)作(zuo)。10.參與GMP自檢工(gong)(gong)作(zuo)11.參與物料(liao)供應商評(ping)估(gu)工(gong)(gong)作(zuo)。12.參與外部審(shen)(shen)(shen)計.委(wei)托生產.委(wei)托檢驗工(gong)(gong)作(zuo)，參與整(zheng)改措施的(de)制(zhi)訂工(gong)(gong)作(zuo)。13.負(fu)責(ze)實驗室安全管(guan)(guan)(guan)理(li)(li)工(gong)(gong)作(zuo)。