Sr Quality Engineer

7 months ago


Suzhou, China Roche Full time

The Position

Main Tasks & Responsibilities主要工作职责 :
1. Management and Coordination of the Monitor external regulatory requirements, notify RDSZ stakeholders as well as driving compliance assessment for further mitigation actions development with business Preparation, review of process documents taking into account the factors influencing the participating functional areas and in accordance with the regulatory Submit the manufacturing registration documents and other required reporting documents Coordinate internal audit program, and ensure that the process is carried out in accordance with the Maintain Quality Management Review process. Prepare inputs for the Quality Management Review. Evaluate Q-data as a basis for corrective and preventive Support to develop and deliver QM related Share the expertise and provide support to the global teams and other sites as China GMP expert when needed.
需要时作为中国医疗器械生产质量管理规范专家向全球团队及其它工厂提供专业意见及支持。

2. IRM Act as SME on IRM process within RDSZ. Ensure the effectiveness of implementation within Drive the implementation of digital IRM modules at RDSZ in PIU QM Module.
负责RDSZ的IRM模块在P1U系统质量模块内的实施。

3. External audit management
外部审计管理
Coordinate authority/notify body audit, including but not limited Logistics preparation for external Documents readiness checklist and SME Audit room and war room set Audit CAPA follow up
审计纠正预防措施追踪

4. Other tasks assigned by line manager 
完成直线领导交办的其他任务


Qualification & Experience任职资格
Education
教育背景

• 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专业,或等同经验。

Qualification & Certification
资质证书
• Competent with routine application of MS Office能够熟练使用MS office办公软件

Experience
工作经验

• 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
• Experience in managing external audit, China NMPA, TUV/BSI, US FDA 
外审迎审方面经验,如中国NMPA、TUV/BSI、US FDA等

Professional Competencies
专业能力:

• Knowledge of the European, US, China and International cGMP regulations
熟悉欧洲,美国,中国和国际cGMP法规



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