職位描述
職位描述：
目的 PURPOSE
本程序旨在明確QA部的文件管理員職責(zé)。
The SOP defines responsibilities of document QA.
范圍 SCOPE
本標(biāo)準(zhǔn)操作規(guī)程適用于凱惠睿智生物科技(上海)有限公司的QA部文件管理員崗位。
The SOP applies to the position of document QA in China Gateway Biologics (Shanghai) Co., LTD.
職責(zé) RESPONSIBILITY
QA部文件管理員遵守本規(guī)程。
Document QA should obey the SOP.
程序 PROCEDURE
1. 組織起草，修訂文件，負(fù)責(zé)GMP質(zhì)量管理文件的管理。
Arrange to draft and modify documents, and responsible for document management of GMP quality system.
2. 按管理規(guī)程對(duì)GMP文件進(jìn)行復(fù)制、分發(fā)、歸檔、保存、借閱、回收和銷毀等工作，并建立文件目錄。
Following related SOPs, copy, distribute, archive, storage, borrow, return, destroy and so on, and build document management sheet.
3. 按管理規(guī)程對(duì)記錄進(jìn)行歸檔、借（查）閱、保存、銷毀等活動(dòng)。
Following related SOPs, archive, borrow, review, storage, destroy and so on.
4. 物料供應(yīng)商檔案的歸檔、保存。
Responsible for management of supplier archives of materials.
5. 政府文件和法規(guī)資料的歸檔，保存。
Responsible for management of authoritative documents and related regulations.
6. 組織GMP文件的會(huì)審及審核活動(dòng)。
Arrange to review and audit for GMP documents.
7. 對(duì)各部門(mén)的文件管理工作進(jìn)行培訓(xùn)、指導(dǎo)、監(jiān)督，并督辦其定期存檔。
Train, guide and check document management related departments.
8. 參與公司的GMP自檢，并對(duì)自檢提出的有關(guān)整改措施進(jìn)行跟蹤管理。
Take part in self-inspection to CMC unit, and trace on related corrective actions.
9. 遵守公司保密制度，對(duì)QA保管的保密文件進(jìn)行專項(xiàng)管理。
Follow secure SOPs, and special management to secret documents stored in QA department.
10. 上級(jí)領(lǐng)導(dǎo)交辦的其它工作。
Perform other duties assigned by Immediate supervise.
管理層次ADMINISTRATIVE LEVEL
直接上級(jí)：QA部經(jīng)理
Immediate supervise: QA manager
任職資質(zhì) JOB QUALIFICATION
1. 學(xué)歷：大學(xué)專科及以上學(xué)歷，制藥、生物技術(shù)、分析技術(shù)等相關(guān)專業(yè)。
Education background: junior college or above, pharmacy, biotechnology, analytical technology and related professions.
2. 經(jīng)驗(yàn)：無(wú)特別要求。
Experience: have no special requires.
3. 其他：能熟練閱讀英文專業(yè)資料；常用文件處理軟件操作熟練，工作細(xì)致謹(jǐn)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.
