ResponsibilitiesLocation Shanghai, ShanghaiCN Job ID JR-023389
- GSP管理和执行, 外部现行法规、标准的收集
- GSP quality management for the commercial sites, External regulation/ standard collection
- Develop, update and optimize company Policies/SOPs and associated documents, ensure Policies/SOPs’ training completion and compliance of all staff, and maintain accurate documentation of SOPs and training files.
- Liaise with manufactures regarding quality follow up, ie. Complaint investigation, AER and recall of products, improvement plans, etc.
- As key quality staff, plan and participate all kinds of internal and external audits, including Periodical onsite service audit and supplier audit for quality and compliance control.
- Liaise with NMPA regarding GSP implementation of all the related regulations and requests
- Certificate, License and stamp management
- LMS management, develop training modules for various quality process sections, identify areas requiring training and ensure gaps are completely filled within given time frame
- Back up with team members regarding QEMS operation
- Bachelor degree or above， with fluent English in both oral and written
- Knowledge of GxPs including regulatory requirements
- Good understanding of ISO9001 & ISO14001 regulations and requirements, knowledge of ISO13485 is plus
- Sound organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact with employees, multidisciplinary groups as well as with vendors.
- Good analytical and issue identification abilities, and attention to detail.
- Capability to identify issue and problem solving.
- Skilled use of tools and applications, for quality statistics and analysis
- Self-starter with high energy level, time management, self-discipline and strong result orientation
- 5 years pharm / medical device MNC experience
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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