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質量注冊部--部門助理-中國-00592 0.8-1萬/月/月

德爾格醫療

上海

大專
03-14 發布

職位信息

職位名稱：質量注冊部--部門助理-中國-00592

類別名稱：

職位描述：

職位描述：職位描述此崗位為臨時崗位，簽訂內部7個月合同The Assistant to Quality & Regulatory Affairs is responsible for assisting the Quality & Regulatory Affairs (QRA) team and Head of Quality & Regulatory Affairs (QRA) to fulfill the regulatory requirements, support regulatory product approvals in China/target countries, implement the quality management system and monitor the product quality performance.崗位職責Regulatory Affairs Support-Coordinate regulatory affairs (RA) activities between Shanghai and Beijing-Prepare monthly RA reports, action list and update accordingly in the filing folders-Manage and archive RA documents including soft and hard copy-Handle RA documents in terms of stamping, signing, passing on documentsQuality & Regulatory Affairs Department Support-Manage administrative tasks of QRA team and functional head like team meetings and cross functional meetings-Generate meeting minutes and action list-Perform fixed assets statistics-Perform daily attendance statistics-Coordinate all team activities within QRA function-Arrange external auditors’ accommodation-Prepare QRA reports according to the requirements of functional head like KPI reportQuality Management System Support:-Maintain training matrixes relevant to Quality Documents and records-Manage and archive hard copies of Quality Documents and records-Register and file training records of quality standardsManage and archive hard and soft copies of Product Quality and Post Market Surveillance任職要求Bachelor degree in administration management or a comparable combination of education and experience2-3 years experiences as assistant or in administrationProfessional-MS office – advanced level-English in written and oral – advanced levelBehavioral-Care about the customer – basic level-Cooperate and communicate – advanced level-Act reliably – advanced level-Drive results – advance level-Learn and develop – advanced level

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