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1. Execute the establishment and maintenance of archive and training administration system as assigned. 按規定執行檔案和培訓管理系統的建立和維護； 2. Execute the operation of archive，training and document administration to maintain compliance with GMP and international regulatory requirements. 執行檔案管理，培訓管理和文件控制的運行，以保持符合GMP和國際法規要求； 3. Write archive，training and document administration related documents. 編寫檔案管理，培訓管理和文件控制相關文件； 4. Participate in the daily activities of the QA Department as assigned. 按規定參與質保部的日?；顒?； 5. Participate in the internal auditing of CBL Wuhan China as required. 根據需要參與鼎康武漢公司的內部審計計劃； 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. 協助主持監管機構、客戶或盡職調查/審計。根據分配與所有部門密切合作，確保及時回復和跟進任何觀察項。