1. Execute the establishment and maintenance of archive and training administration system as assigned. 按規(guī)定執(zhí)行檔案和培訓(xùn)管理系統(tǒng)的建立和維護(hù); 2. Execute the operation of archive,training and document administration to maintain compliance with GMP and international regulatory requirements. 執(zhí)行檔案管理,培訓(xùn)管理和文件控制的運行,以保持符合GMP和國際法規(guī)要求; 3. Write archive,training and document administration related documents. 編寫檔案管理,培訓(xùn)管理和文件控制相關(guān)文件; 4. Participate in the daily activities of the QA Department as assigned. 按規(guī)定參與質(zhì)保部的日?;顒?; 5. Participate in the internal auditing of CBL Wuhan China as required. 根據(jù)需要參與鼎康武漢公司的內(nèi)部審計計劃; 6. Assist in hosting regulatory, customer or due diligence audits. Work closely with all departments as assigned to ensure timely responses and follow-up of any observations. 協(xié)助主持監(jiān)管機構(gòu)、客戶或盡職調(diào)查/審計。根據(jù)分配與所有部門密切合作,確保及時回復(fù)和跟進(jìn)任何觀察項。