【正文】 ityrelated affairs, including but not limited。⑴.全面負責QA和QC的工作；Taking full charge of QA/QC job。⑵.確保GMP的實施和質量體系的改進；Ensuring the implement of cGMP and the improvement of quality system。⑶.審核批準所有質量相關的文件和事務；Review and approve all the quality related document and affairs。⑷.負責國內SFDA和國外FDA、WHO、EDQM以及客戶的審計；Be responsible for regulatory audit from US FDA, WHO, SFDA and other customer。⑸.負責GMP和其它藥政法規(guī)的培訓工作；Be responsible for the GMP training and pharmaceutical regulations。主要成績Major Achievement:⑴.完成了兩個API產品的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API產品于2012年3月順利通過了WHO的現場審計；Past WHO site audit successfully in March 2012。.⑶.在擔任質量負責人期間，公司的質量水平得以明顯改善，做到無質量投訴、無質量事故。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 擔任職務：藥品生產質量管理 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，做質量工程師5年；n 從事QA產品主管2年；n 從事法規(guī)事務高級經理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． 負責SOP、BPR等文件系統(tǒng)的編制Preparation of document system, such as SOP and BPR。⑵． 負責生產工藝和質量體系的改進Improvement of product process and quality system。⑶． 負責產品放行、供應鏈管理以及產品回顧、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． 負責DMF的編制、遞交和修訂Preparation, submission and update of DMF。⑸． 負責SFDA、EDQM、FDA和其它國內外客戶審計Regulatory audit, such as SFDA, EDQM, FDA and other customers。主要成績Major Achievement⑴.在擔任車間工程師期間（20002005年），為適應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.在擔任QA主管期間（20062007年），編制了兩個API產品的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.在擔任法規(guī)事務高級經理期間（20082010年），順利完成了3起歐盟EDQM現場審計和3起美國FDA現場審計。其中2010年7月以零缺陷通過了FDA審計。此外主導了默克、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。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.在擔任法規(guī)事務高級經理期間（20082010年），主動與EDQM溝通，成功的說服EDQM將某一特定雜質收錄到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.