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(Senior) QA Specialist

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Location: Shanghai, China
Position Type: Fixed-Term
Job Function: Quality

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Ensure compliance status for labeling related info including package insert, box label and so on, on finished goods according to China regulation requirement.
Coordinate providing product labeling and documentation to support registration and business.
根据中国法规要求,确保标签相关信息合规
协调提供产品标签和说明书以支持注册和业务 

 

主要职责 / MAIN ACCOUNTABILITIES

  • Establish and lead labeling management process from new product introduction to change management after launch including both clinical and Industry product;、
  • 建立和领导标签管理,范围包括临床和工业产品从新产品上市到产品变更管理。
  • Closely work with Global PLD to align practice and adapt to local requirement(for example UDI) if need;
  • 与总部的标签管理团队紧密合作,根据本地要求(例如UDI)达成一致的操作
  • Proactivity work with Global PLD, Regulatory Affairs, Marketing and Application Specialist to finalize package insert and labeling content translation and review according to China regulation requirement;
  • 根据中国法规要求,主动与总部标签团队,注册事务部,市场部以及产品应用专员合作完成产品说明书和标签的翻译和校对工作
  • Closely work with supply chain team to manage the product label related data updating
  • 和供应链密切合作,管理好标签相关数据的更新。
  • Maintain the product label master data, and deliver related information to cross function as well as upload to related platform according to local regulation requirement when needed
  • 维护标签主数据库, 需要时将相关信息传递给相关部门以及根据法规要求上传至相关平台。
  • Support the internal and external audit
  • 支持内部和外部审核

 

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

  • Education background: biological Engineering, Pharmaceutical related are preferred. / 教育背景:生物工程,药学等相关专业优先
  • 2~5 years of RA/QA working experience or product labeling management  preferred. / 2~5年RA/QA工作经验者和标签管理工作经验者优先
  • Good command of English in both written and oral. /书面口头英语熟练
  • Good communication and interpersonal skills. / 良好的沟通技能。
  • Team work and take initiatives. self-discipline and work independently / 团队合作精神、主动工作、具有较强自律能力并能独立工作
  • Work under pressure. / 抗压能力强
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