静安-知名药企招医药质量助理 上海

月薪： 6-8千/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 02-25 发布
  • 五险一金
  • 节日福利

职位描述

JOB PURPOSEAssist to implementation and maintenance of an appropriate Affiliate Quality System in compliance both with Sanofi Quality Policy, Quality Directives & Standards and regulatory requirements, concerning all activities related to the clinical investigation, distribution and marketing of all products developed and/or marketed in the country of Sanofi or through partnership agreements.Handle product complaints and quality events.ORGANIZATIONAL CONTEXT(See the related Organizational Chart supporting document)SUPERVISED RESOURCES(Sales, budget, headcount…)KEY ACCOUNTABILITIESl Quality of Affiliate Operations o Quality Systemn Support to define, implement and maintain a local quality system applying to affiliate GxP and health-regulated activities related to the development, manufacturing, distribution and commercialisation of all products under development or marketed in the country by Sanofi or through partnership agreements, in compliance with Quality reference standards;n Promote Quality mindset into the affiliate governance, working principles and ways of operating;n Quality Review— Support the Carry-out of annual Quality Reviewn GxP regulatory inspections:— Assist the management of regulatory inspections pertaining to GxP processes owned by the CQH, and provide support and coordination to other affiliate functions in the event of inspections by Regulatory Authorities for processes they own, ensuring contribution of concerned functions at operational unit level (as needed)n Corrective and Preventive Actions (CAPA)— Implement the CAPA process at the affiliate in compliance with the local requirement.n Affiliate Quality Performance Indicator— To report the affiliate quality performance indicators per requesto Affiliate Overall Quality Mattersn Non-product related quality eventsSupport to escalate the events occurring at the affiliate according to defined process.l Quality of Productso Product Complaints (PC)n Manage product complaints received by the affiliate according to company processes, standards and appropriate tools in force, in connection with the operational quality unit in charge of affiliates and the concerned Global Quality function, as appropriaten Conduct product complaints trend analysis and signal detection, as appropriateo Product-related Quality Eventsn Support to escalate quality events occurring at the affiliate according to defined processes and standards and manage subsequent quality alerts (as appropriate)l Other Tasks assigned by the ManagementEDUCATIONUniversity degree or equivalent in Pharmaceutical Engineering, Bioscience, Chemistry, or relevant subjects.EXPERIENCE & KNOWLEDGEl Fluent in Chinese and English speaking and writingl Experience in industrial or affiliate quality system management is preferredCORE COMPETENCIESl Capability to work in highly matrix organization l “Can Do” attitude 职能类别： 生物工程/生物制药

联系方式

上海静安嘉里

公司信息

北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业最具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。 成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。 FESCO Adecco致力于成为最专业的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。

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