职位描述
职位描述：
目的 PURPOSE
本程序旨在明确QA部的文件管理员职责。
The SOP defines responsibilities of document QA.
范围 SCOPE
本标准操作规程适用于凯惠睿智生物科技(上海)有限公司的QA部文件管理员岗位。
The SOP applies to the position of document QA in China Gateway Biologics (Shanghai) Co., LTD.
职责 RESPONSIBILITY
QA部文件管理员遵守本规程。
Document QA should obey the SOP.
程序 PROCEDURE
1. 组织起草，修订文件，负责GMP质量管理文件的管理。
Arrange to draft and modify documents, and responsible for document management of GMP quality system.
2. 按管理规程对GMP文件进行复制、分发、归档、保存、借阅、回收和销毁等工作，并建立文件目录。
Following related SOPs, copy, distribute, archive, storage, borrow, return, destroy and so on, and build document management sheet.
3. 按管理规程对记录进行归档、借（查）阅、保存、销毁等活动。
Following related SOPs, archive, borrow, review, storage, destroy and so on.
4. 物料供应商档案的归档、保存。
Responsible for management of supplier archives of materials.
5. 政府文件和法规资料的归档，保存。
Responsible for management of authoritative documents and related regulations.
6. 组织GMP文件的会审及审核活动。
Arrange to review and audit for GMP documents.
7. 对各部门的文件管理工作进行培训、指导、监督，并督办其定期存档。
Train, guide and check document management related departments.
8. 参与公司的GMP自检，并对自检提出的有关整改措施进行跟踪管理。
Take part in self-inspection to CMC unit, and trace on related corrective actions.
9. 遵守公司保密制度，对QA保管的保密文件进行专项管理。
Follow secure SOPs, and special management to secret documents stored in QA department.
10. 上级领导交办的其它工作。
Perform other duties assigned by Immediate supervise.
管理层次ADMINISTRATIVE LEVEL
直接上级：QA部经理
Immediate supervise: QA manager
任职资质 JOB QUALIFICATION
1. 学历：大学专科及以上学历，制药、生物技术、分析技术等相关专业。
Education background: junior college or above, pharmacy, biotechnology, analytical technology and related professions.
2. 经验：无特别要求。
Experience: have no special requires.
3. 其他：能熟练阅读英文专业资料；常用文件处理软件操作熟练，工作细致谨慎。
Other; read English professional data and translate fluently, familiar with current software with office, word handle, another, should be careful and caution to works.
