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GSP Manager

Shanghai, China

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Location Shanghai, ShanghaiCN Job ID JR-023389


  • GSP管理和执行, 外部现行法规、标准的收集
  • 开发、更新并优化公司的政策/SOP以及相关文件,确保政策、SOP的培训、确保员工合规执行、同时维护文件、流程以及培训资料,确保文件准确
  • 与工厂联系跟踪与质量相关的任务,比如投诉调查,产品的可接受误差率以及召回,改善计划等
  • 作为主要的质量成员,计划并参与各项内外部的审核,包括出于质量和合规控制的考虑,定期完成现场维修审核以及供应商审核等
  • 与当地药监监管机构保持联系,确保公司关于GSP规范要求的执行
  • 证照、公章的管理
  • LMS的管理,针对不同质量流程模块开发培训资料,辨识培训需求,并确保在既定的时间内完成培训消除隐患
  • 支援团队其他成员QEMS体系的运营

Key Responsibilities:

  • 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


  • 本科院校,英文口语书写流利
  • 熟悉GXP的相关规范和要求
  • 熟悉9001和14001的规范要求,了解13485要求尤佳
  • 优秀的组织、沟通和团队协作能力,擅长人际沟通,能够有效的与其他员工、多组织以及供应商互动
  • 优秀的分析及识别能力,注意细节
  • 发现问题解决问题的能力
  • 熟练使用软件或工具,用于质量统计及分析
  • 具有较强的自我驱动力,时间管理,自律并且以结果为导向
  • 5年药企/医疗器械相关的大型外资企业工作经验

Job Requirements:

  • 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

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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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