要求：

(a) Academic / Major学历 /专业

Bachelor degree or above in Medical, Pharmacology or Biology related major.

医学、药学及生物学相关专业本科以上学历。

(b) Professional Skills专业技能要求

Adequate knowledge of new drug development, clinical operation, local regulation, GCP & Chinese GCP. Got GCP certificate.

掌握药物开发、临床试验流程，熟悉相关法规，GCP&中国 GCP，并获得GCP 证书。

(c) Working Experience 工作经验要求

At least 2 years QA & Training working experience; experience global company audit is preferred.

至少两年QA 或培训工作经验；有跨国企业工作经历者优先。

(d) Language ability 语言能力

Fluent in both written and oral English.

流利的英语书写和口语能力。

(e) Computer Literacy 电脑相关知识

Good at Microsoft offices.

擅长微软办公软件。

(f) Other abilities such as Communication skills\Information-gathering skills 本职位要求的其他能力：如沟通能力\信息收集能力等

NA

(g) Tigermed Cultural Requirements 泰格的文化要求

Integrity, honesty and professionalism. 正直诚信、实事求是、敬业合作。


一、 Responsibilities 工作职责
(a) 建立、修改、更新并完善SOPs 及维护、管理SOPs SOP management
1.建立及完善英放SOP。
Set up and develop FAB SOP.
2.根据SOP 要求，协助定期审阅SOP 是否符合现行操作及法规。
According to SOP, Periodically review SOP and check if it comply with the existing regulatory requirements and operation procedure.
3.确保与泰格总体SOP 一致性，并补充完善医学影像特殊要求所需的SOPs。
Ensure consistency with the Tigermed general SOP and develop the specific SOPs which are applicable for imaging CRO practice.
(b)为保证质量体系而进行的稽查活动
Audit activities for QMS assurance
1.为保证临床试验质量，定期对英放内部临床试验项目的操作和管理进行稽查。参与公司内部稽查计划制定、执行与递交稽查报告。
To ensure trial quality, periodically conduct audit for clinical trial operation and management. To involve in developing internal audit plan, implementation and issue audit report
2.审阅所有稽查报告的回复及跟进，并汇总稽查问题，给项目组成员进行培训。
Review and tracking all the audit response report and provide training to project team member in terms of audit findings.
3.履行合同外部稽查 contractual external audit.
4.负责和泰格QA 沟通、交流和协调。
Responsible for communication and coordination with QA team of Tigermed.
(c)对员工的培训
Staff Training
1.对新入职相关人员进行SOP 培训。
Provide SOPs training to new staff.
2.指导各部门SOP 培训，并建立员工培训记录，定期对这些记录进行检查，确保更新及完整。Guide and nominate each department to deliver SOP training as well as set up personnel training record and periodically checking to ensure updating & integrity.
3.制定月培训计划，负责执导或协调各部门相关人员给予员工进行技能提升培训
Make monthly training plan and conduct training or coordinate with relevant department to nominate person to provide training.
4.负责将英放周及月培训的课件进行存档并保管。
Resposible for archiving and uploading files to designated folders of FAB/Tigermed;
(d)协助完成，但不局限于，商业发展部安排的指定任务
Assist other assignments from Business Development Dept.
1.开票、款项跟进、付款等。
Invoices、tracking、payment.
2.协助完成软件著作权、政府基金的申请工作。
Assist the application of software copyright and the government fund.
3.协助总经理规划、协调、掌握公司项目进程的全貌，进行资源合理调配和安排；
Assist General Manager to oversee the progress of ongoing projects, outline the risk management and preventive measures, coordinate resources to smoothen the project running;
4.协助PM 协调独立阅片者的安排
Assist Project Manager to coordinate the arrangement of independent reviewers.