職位描述
POSITION SUMMARY（職位概述）
Plan and conduct corporate document management.
計劃、執行公司文件管理。
KEY RESPONSIBILITIES（主要職責）
1. Set up and maintenance the management rules for electronic system and paper system, and ensure it under the well compliance with the corporate/ISO/GB/regulation/GMP requirements.
建立和維護公司文件管理系統（電子系統和紙面系統）并確保其滿足公司/ISO/GB/相關法規和GMP的要求。
2. Responsible for management all paper and electronic version GMP documents and blank record sheet for preparing, reviewing, approval, effective and distribution. And supervise its implementation meet GMP requirements.
負責管理公司所有紙質和電子版本GMP文件和空白記錄的起草、審核、批準、生效、分發等工作，并監督其符合GMP規范要求。
3. Ensure all technical related documents/drawing are approved and archived in compliance corporate policies. Responsible for technical related documents borrowing management.
確保所有技術相關文件/圖紙的批準和存檔符合公司政策的規定。負責技術文件的借閱工作。
4. Responsible for archiving and management for executed batch record
負責已執行批記錄的存檔和管理。
5. Responsible for DCC system management and training as a super user.
負責公司電子文件系統的管理和培訓，并作為管理員用戶管理系統。
6. Responsible for regulatory document and update
負責法規文件的收集和更新。
7. Other work need to do.
任何其他安排的工作。
SKILLS AND ABILITIES（技能）
1. Above bachelor degree of pharmacy, medical device or relevant. Working experience on electronic documentation system management is preferred.
藥學、醫療器械或相關專業，本科或以上學歷畢業；具有電子文件管理系統管理經驗優先。
2. 3 years’ experience for QA.
相關QA工作經驗3年以上；
3. Good English in reading and writing.
良好的英語讀寫能力。
4. GMP/ISO13485 knowledge as basic for the role
具備GMP/ISO 13485相關知識
5. Good communicate and learning skill.
良好的溝通技巧、學習能力；
6. Skill of Microsoft office.
電腦辦公軟件應用熟練；
