文件体系QA经理/主管-宁波

工作内容 Work Content
1.档案室的管理Archive Management
1.1 负责档案室的文件管理。Responsible for the management of the archives room.
1.2 维护QA档案室文件清单。Responsible for maintaining the Document List in QA Archives.
1.3 负责档案室的温湿度记录和维护。Responsible for recording and maintaining the temperature and humidity of the archives room.
2. 文件的管理 Management of Document and File
2.1 按照SOP要求对GMP文件进行接收、登记、复印、分发、收回、借阅、作废、销毁。Receive, register, copy, distribute, recall, lend, obsolete and destruct GMP document according to SOP requirements.
2.2 负责本部门文件、档案的借阅登记，保管工作。Responsible for lending, registering and archiving the documents and
files in QA department.
3. 分析文件的管理 Management of Analytical Document
3.1 严格按照SOP对GMP分析文件进行接收、登记、复印、分发、收回、借阅、作废、销毁。Receive, register, copy, distribute, recall, lend, obsolete and destruct GMP analytical document exactly according to SOP.
3.2 负责分析文件电子存档的管理工作。Manage electronic documentation for analytical documentation.
4. 记录管理Record Management
4.1 负责QA控制记录模板的发放、登记、回收、存档借阅等工作。Responsible for the issuance, registration, recovery and archiving of QA control records template.
4.2 监督记录的变更应符合程序要求，与记录相关的偏差应及时报告和处理。Supervise that the change for record is compliant with requirement; deviation related with record should be reported and handled on time.
4.3 定期对各种文件、记录进行整理、核对。Organize and check all the documents and records at regular intervals.
4.4 负责外印记录的管理。Responsible for the management of externally printed records.
5. 培训管理 Training Management
5.1 制定QA部门的季度培训计划和年度培训计划，对培训计划执行情况进行跟踪。Make the quarter training plan and annual training plan of QA department, follow up the implementation of the training plan.
5.2 审核整理保存其他部门的员工档案，部门季度培训计划等。Review, organize and save employee files, departmental quarter training plan etc.
5.3 组织各部门的课堂培训和新员工入职的GMP培训。Organize classroom training of all departments and GMP training for new employees.
5.4 负责培训效果评估的管理。Responsible for the management of training effectiveness evaluation.
5.5 负责培训讲师的管理。Responsible for the management of trainer.
6. DMS系统管理DMS System Management
6.1 负责参与DMS系统的验证相关工作。Participate in the DMS system validation.
6.2 作为部门文件管理员，参与DMS系统的管理。As the department document manager, participate in the management of DMS system.
7. TMS系统管理 TMS System Management
7.1 负责参与TMS系统的验证相关工作。Participate in the TMS system validation.
7.2 作为部门培训专员，参与TMS系统的管理。As the department training manager, participate in the management of TMS system.
8. QMS系统管理 QMS System Management.
8.1 负责参与QMS系统的验证相关工作。Participate in the QMS system validation.
8.2 作为QA部门QMS系统SME，参与QMS系统的管理。As the QMS system SME in QA department, participate in the management of QMS system.
9. CAPA管理CAPA Management
9.1 负责在QMS系统中CAPA计划的批准。Responsible for the approval of the CAPA plans in QMS system.
9.2 负责在QMS系统中CAPA实施结果的批准。Responsible for approving the implementation results of CAPA in QMS system.
9.3 负责在QMS系统中CAPA延期、修订、撤销的管理。Responsible for managing the extension, revision, and withdrawal of CAPA in QMS system.
9.4 负责在QMS系统中CAPA有效性评估的批准。Responsible for approving the effectiveness evaluation of CAPA in QMS system.
10. 变更管理 Change Management
10.1 负责文件、培训、虫害控制等相关变更的审核。Responsible for reviewing related changes in documents, training,
pest control, etc.
10.2 负责变更发号及归档。Responsible for issuing change numbers and archiving changes.
11. 虫害控制管理 Pest Control Management
11.1 负责虫害控制综合防制方案的批准。Responsible for approving the comprehensive pest control prevention
and control plan.
11.2 负责虫害控制月度报告的批准。Responsible for approving the monthly pest control report.
11.3 负责虫害控制年度报告的批准。Responsible for approving the annual pest control report.
12. 设备验证管理 Equipment Validation Management
12.1负责设备验证和确认的相关文件审核和批准。Responsible for review and approval of equipment validation and
qualification documents.
12.2 审核和批准设备验证和确认相关的变更。Review and approve the equipment validation and qualification
related change control.
13. 负责法规月度查新。Responsible for monthly regulatory surveillance.
14. 负责客户调查问卷的填写。Responsible for filling out the customer questionnaires.
15. 负责质量协议的审核及管理。Responsible for the review and management of quality agreements.
16. 负责访问权限的管理。Responsible for the access control management.
17. 负责内部审计和外部审计的文件准备和管理。Responsible for the internal and external audit document preparation
and management.
18. 完成本部门领导临时安排的工作。Complete any interim arrangements arranged by the leadership of the department.t.

教育背景和任职资格 Education Background And Qualification
1.教育背景Education Background: 制药、英语、科技英语或其他相关专业本科及以上学历，硕士学历优先。Education: A bachelor's degree or above in Pharmaceutical English, Scientific English or other related majors, Master degree is a plus.
2.工作经验：5年以上制药行业体系QA和文件QA的工作经验，2~3年管理团队的经验。