职位描述
POSITION SUMMARY（职位概述）
Plan and conduct corporate document management.
计划、执行公司文件管理。
KEY RESPONSIBILITIES（主要职责）
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.
建立和维护公司文件管理系统（电子系统和纸面系统）并确保其满足公司/ISO/GB/相关法规和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.
负责管理公司所有纸质和电子版本GMP文件和空白记录的起草、审核、批准、生效、分发等工作，并监督其符合GMP规范要求。
3. Ensure all technical related documents/drawing are approved and archived in compliance corporate policies. Responsible for technical related documents borrowing management.
确保所有技术相关文件/图纸的批准和存档符合公司政策的规定。负责技术文件的借阅工作。
4. Responsible for archiving and management for executed batch record
负责已执行批记录的存档和管理。
5. Responsible for DCC system management and training as a super user.
负责公司电子文件系统的管理和培训，并作为管理员用户管理系统。
6. Responsible for regulatory document and update
负责法规文件的收集和更新。
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.
药学、医疗器械或相关专业，本科或以上学历毕业；具有电子文件管理系统管理经验优先。
2. 3 years’ experience for QA.
相关QA工作经验3年以上；
3. Good English in reading and writing.
良好的英语读写能力。
4. GMP/ISO13485 knowledge as basic for the role
具备GMP/ISO 13485相关知识
5. Good communicate and learning skill.
良好的沟通技巧、学习能力；
6. Skill of Microsoft office.
电脑办公软件应用熟练；
