公用系統驗證工程師的崗位職責是什么?
問 不知道公用系統驗證工(gong)程(cheng)師主要是做(zuo)什么(me)的?有(you)知道的可以(yi)分享一下嗎?
答 1、負(fu)責公用系(xi)統(tong)(tong)(tong)、凈化類(lei)設備的再(zai)驗(yan)(yan)(yan)(yan)證(zheng)方案(an)的起(qi)草(cao),審核; 2、協助安排驗(yan)(yan)(yan)(yan)證(zheng)組人員配合工程(cheng)部門進行(xing)年度的高(gao)效過濾器(qi)PAO檢漏(lou)、風速、風量測試等工作; 3、審核計(ji)算機(ji)驗(yan)(yan)(yan)(yan)證(zheng)相(xiang)關(guan)文(wen)(wen)件,根據公司設備及系(xi)統(tong)(tong)(tong)的實際情況,起(qi)草(cao)計(ji)算機(ji)驗(yan)(yan)(yan)(yan)證(zheng)相(xiang)關(guan)方案(an); 4、負(fu)責審核新(xin)建工程(cheng)項目的驗(yan)(yan)(yan)(yan)證(zheng)相(xiang)關(guan)文(wen)(wen)件; 5、協助管(guan)理(li)(li)第三方公司; 6、負(fu)責驗(yan)(yan)(yan)(yan)證(zheng)文(wen)(wen)件的歸檔及管(guan)理(li)(li); 7、協助QC部門進行(xing)水系(xi)統(tong)(tong)(tong)、工藝氣體(ti)系(xi)統(tong)(tong)(tong)的日常(chang)監控趨勢分析工作,如有異常(chang)參與(yu)調(diao)查,并提(ti)供驗(yan)(yan)(yan)(yan)證(zheng)支持; 8、有良好的英語(yu)讀寫(xie)交(jiao)流能力,中(zhong)英文(wen)(wen)文(wen)(wen)件翻譯能力; 9、熟知(zhi)制(zhi)藥(yao)行(xing)業文(wen)(wen)件系(xi)統(tong)(tong)(tong),國內外GMP等最新(xin)法規。