 Qualification and Validation/Change Control
验证确认和变更控制
• Qualifications are planned and checked / released in compliance with regulation requirements (e.g China Medical device GMP, and ISO 13485).
根据各项医疗器械法规（e.g GMP, ISO 13485）要求规划及检查/放行系统确认。
• The qualification and validation activities are performed together with the owner departments in accordance with the specifications as well as being processed in due time and documented.
根据规范与用户部门共同执行确认及验证活动，且在规定时间内处理并形成文件。
• Provide consultancy to all functional units regard to qualification/validation queries and support the qualification/validation implementation.
向所有职能部门提供有关确认/验证问题的咨询，并支持确认/验证的实施。
• Facilitate the qualification/validation related workshops to ensure compliance understanding from participants.
支持确认/验证相关研讨会，以确保参与者理解合规要求。
• Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions.
与负责的职能部门共同描述并实施系统和设备确认概念。
• The valid status is maintained as per the control and follow-up of periodic reviews.
根据定期回顾的控制措施和跟踪行动维护验证状态。
• Support Non-conformity report initiated during qualification/validation.
支持确认/验证期间发起的不符合调查。
• Quality Review of change initiated in responsible areas, focus on validation/qualification task accuracy.
负责区域相关变更的质量审核, 关注验证/确认任务的准确性。

 IRM and CAPA Management
改进和解决方案管理及纠正预防措施管理
• Review and release of Nonconformity reports are carried out in accordance with the specifications.
参照要求审核和批准不符合报告。
• If necessary, review record occasionally from compliance point view,
如需要，不时的从合规角度审阅记录。
• Any technical meetings are managed in accordance with the specifications.
参照要求管理技术会议。
• Perform final closure of CAPA cases in accordance with the specifications.
参照要求实施纠正预防错案例关闭。
• The local regulation requirements of the QMS are complied with during the implementation of the CAPA actions, amongst other things by means of a Q-review before the completion of CAPAs and a Q-review of quality notifications that are prepared in the course of CAPAs/product problems/ complaints.
在实施纠正预防措施行动期间，要遵守质量管理体系当地法规要求，其中包括在纠正预防措施关闭之前进行质量审核以及质量通知审核来源于纠正预防措施/产品问题/投诉。

 Other tasks assigned by line manager
完成直线经理交办的其他任务。

任职资格：
• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
本科或研究生，生命科学，数据科学或其他相关/等同专业。
• Competent with routine application of MS Office能够熟练使用MS office办公软件
• At least two (2) years in the Medical Device/Pharma/Biopharmaceutical industry
2年以上医疗器械，制药或生物制药企业
• Knowledge of the European, US, China and International cGMP regulations
熟悉欧洲，美国，中国和国际cGMP法规