Job Summary职位概述:
The job holder ensures to meet / perform 该职务确保能达到或履行：
- Validation/Qualification system maintenance and management
验证/确认体系的维护与管理
- Change control NCR control and CAPA system maintenance and optimization
变更控制、不合格控制和CAPA体系的维护与优化
- Evaluation and action tracking of specific validations, changes, non-conformities, CAPA cases
具体验证、变更、不合格、CAPA 案例的评估和行动跟踪。

Main Tasks & Responsibilities主要工作职责:
- Responsible for organizing validation and qualification for equipment, computerized system and process within QMS on the basis of regulatory standards. Continuing to monitor and optimize qualified equipment, system and process, and validation/qualification system as well.
在质量体系框架内并基于法规要求，负责设备、计算机化系统和工艺的验证组织与管理。持续监控和优化已验证的设备、系统和工艺，以及持续优化验证/确认流程。
- Responsible for change, NCR and CAPA management, identification, organizing, following up to comply with QMS and regulation requirements. And continue to improve relevant process and to optimize QMS.
负责管理、识别、组织、跟踪变更、不合格与CAPA，使其符合质量管理体系和法规的要求，并持续改进相关流程，促进质量体系持续优化。
- Assisting and organizing routine quality affairs including product design process control from a compliance perspective to ensure process compliance and effectiveness and pilots batch record release and QMS documents review
协助和组织日常质量事务，包括新项目开发过程控制，保证开发过程的合规和有效性，试生产批记录放行，标签说明书流程控制、质量体系文件审核等。
- Participating in internal and external audit in an efficient and effective way to positively sustain the overall QMS, and actions following up as well.
高效率有效地参与内外部审核以及后续行动的跟踪以维护质量体系的有效性。
- Complete other tasks arranged by line manager.
完成 直线经理安排的其他工作。

Education& Qualifications教育背景与专业资格:
- Bachelors Degree in Biology, Medicine, Engineering or Science
生物、医药、工科或理科学士学位
- Masters Degree preferred.
硕士学历优先

Experience工作经验:
- Experience managing or deep involvement in Qulification/Validation, NCR, Change, CAPA in the IVD industry (>3 yrs).
有在IVD行业中验证、NCR、变更、CAPA的管理经验或深度参与经验（> 3年）。
- Experience in ISO 13485 and/or MDSAP building and maintenance is preferred.
具有ISO13485和/或 MDSAP体系建立与维护经验优先。

Language skills 语言能力
Proficient language skills (written and spoken) in Chinese and English
熟练的中文和英文语言能力（书面和口语）

Professional Competencies/skills专业能力/技能:
- Diligent with attention to detail
注重细节
- Collaborates well, while also is capable of dealing with conflict resolution
- 合作良好，同时也能够解决冲突
- Team player with the ability to work on their own initiative
能够主动工作的团队合作者
- Effective communicator at all levels
与不同级别的有效沟通