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【正文】 e for the GMP training and pharmaceutical regulations。主要成績Major Achievement:⑴.完成了兩個(gè)API產(chǎn)品的DMF，以及DMF在WHO和USFDA的注冊；Completed two APIs DMF preparation and submission to WHO and US FDA。⑵.兩個(gè)API產(chǎn)品于2012年3月順利通過了WHO的現(xiàn)場審計(jì)；Past WHO site audit successfully in March 2012。.⑶.在擔(dān)任質(zhì)量負(fù)責(zé)人期間，公司的質(zhì)量水平得以明顯改善，做到無質(zhì)量投訴、無質(zhì)量事故。During the period of quality head, the pany quality level was improved and no quality plaint/no quality incident was available. 2000年07月2010年07月山東新華制藥股份有限公司 [10年]公司行業(yè)：制藥生物工程 公司規(guī)模：10015000 職員 擔(dān)任職務(wù)：藥品生產(chǎn)質(zhì)量管理 所在部門：QA 工作描述：就職于山東新華制藥股份有限公司, 其中:n 從事API生產(chǎn)，做質(zhì)量工程師5年；n 從事QA產(chǎn)品主管2年；n 從事法規(guī)事務(wù)高級經(jīng)理3年；Serviced in Shandong Xinhua Pharmaceutical Co., Ltd for 10 Engaged in production as quality engineer for 5 years。n Engaged in QA as supervisor for 3 years。n Engaged in regulatory affairs as senior manager for 2 years.⑴． 負(fù)責(zé)SOP、BPR等文件系統(tǒng)的編制Preparation of document system, such as SOP and BPR。⑵． 負(fù)責(zé)生產(chǎn)工藝和質(zhì)量體系的改進(jìn)Improvement of product process and quality system。⑶． 負(fù)責(zé)產(chǎn)品放行、供應(yīng)鏈管理以及產(chǎn)品回顧、偏差、OOS、變更、客戶投訴等的處理Product release。management of supplier chain。handling of APR, deviation, OOS, customer plaint, change control, etc。⑷． 負(fù)責(zé)DMF的編制、遞交和修訂Preparation, submission and update of DMF。⑸． 負(fù)責(zé)SFDA、EDQM、FDA和其它國內(nèi)外客戶審計(jì)Regulatory audit, such as SFDA, EDQM, FDA and other customers。主要成績Major Achievement⑴.在擔(dān)任車間工程師期間（20002005年），為適應(yīng)EP藥典要求，%%以下。During the period of quality engineer(Y20002005), reduced an unknown impurity in API from % to less than % through process improvement based on the new requirement of 。.⑵.在擔(dān)任QA主管期間（20062007年），編制了兩個(gè)API產(chǎn)品的DMF，并完成DMF在EDQM，以及巴西、德國、丹麥、俄羅斯等國家的注冊； During the period of QA supervisor(Y20062007), Prepared two API DMFs and pleted DMF registration in EDQM, Brazil, Germany, Denmark, Russia, etc.⑶.在擔(dān)任法規(guī)事務(wù)高級經(jīng)理期間（20082010年），順利完成了3起歐盟EDQM現(xiàn)場審計(jì)和3起美國FDA現(xiàn)場審計(jì)。其中2010年7月以零缺陷通過了FDA審計(jì)。此外主導(dǎo)了默克、拜耳、葛蘭素史克、賽諾菲安萬特、惠氏等多起國外客戶的審計(jì)。During the period of senior manager of regulatory affairs(Y20082010), pleted three times EDQM site inspection, three times US FDA site inspection them, pass the FDA audit with zero observation in July , presided many times foreign customers’ audit, such as Merck, Bayer, GSK, Sanofiavantis, Wyeth, etc.⑷.在擔(dān)任法規(guī)事務(wù)高級經(jīng)理期間（20082010年），主動(dòng)與EDQM溝通，成功的說服EDQM將某一特定雜質(zhì)收錄到CEP證書中。隨后基于EDQM的要求，共同完成了EP專論01/2008:1346的修訂。During the period of senior manager of regulatory affairs(Y20082010)，Communicated with EDQM positively and convinced EDQM to include a specified impurity into CEP certificate successfully and the limit was set according to the requirement of CEP , EP monograph(01/2008:1346)was also updated to included the new impurity based on our technical support.
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