職位描述
POSITION SUMMARY（職位概述）
Plan and conduct corporate document management.
計劃、執(zhí)行公司文件管理。
KEY RESPONSIBILITIES（主要職責(zé)）
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(hù)公司文件管理系統(tǒng)（電子系統(tǒng)和紙面系統(tǒng)）并確保其滿足公司/ISO/GB/相關(guān)法規(guī)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(fù)責(zé)管理公司所有紙質(zhì)和電子版本GMP文件和空白記錄的起草、審核、批準(zhǔn)、生效、分發(fā)等工作，并監(jiān)督其符合GMP規(guī)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(shù)相關(guān)文件/圖紙的批準(zhǔn)和存檔符合公司政策的規(guī)定。負(fù)責(zé)技術(shù)文件的借閱工作。
4. Responsible for archiving and management for executed batch record
負(fù)責(zé)已執(zhí)行批記錄的存檔和管理。
5. Responsible for DCC system management and training as a super user.
負(fù)責(zé)公司電子文件系統(tǒng)的管理和培訓(xùn)，并作為管理員用戶管理系統(tǒng)。
6. Responsible for regulatory document and update
負(fù)責(zé)法規(guī)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(xué)、醫(yī)療器械或相關(guān)專業(yè)，本科或以上學(xué)歷畢業(yè)；具有電子文件管理系統(tǒng)管理經(jīng)驗(yàn)優(yōu)先。
2. 3 years’ experience for QA.
相關(guān)QA工作經(jīng)驗(yàn)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(guān)知識
5. Good communicate and learning skill.
良好的溝通技巧、學(xué)習(xí)能力；
6. Skill of Microsoft office.
電腦辦公軟件應(yīng)用熟練；
