JD基本信息
岗位职责
Job title职位名称: QC System Key Users & Business Owner QC系统管理专员
• Location工作地点: Shenzhen 深圳
• % Remote working and % of travel expected 远程办公和出差的概率:5%
• Job type工作类型 (Full time全职, Part time兼职,Outsource外包,Temporary临时): Full time 全职
• Site/Unit 区域/事业部:Shenzhen site 深圳工厂
About the job工作职责
Our Team我们的团队:
Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.
制造与供应事业部包含以3个全球事业部为基础的制造平台,以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。
Main responsibilities职责描述:
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
• Overseeing all quality processes and digital solutions related to quality control management in compliance with the Sanofi global processes and quality control tools 监督所有与质量控制管理相关的质量流程和数字解决方案,确保符合赛诺菲全球流程和质量控制工具
• Ensuring issuance and approval of all appropriate local quality control documentation, such as local procedures, templates to support the QC processes and QC digital system usage, in the QC labs, in accordance with the Sanofi global processes. 确保发布和批准所有适当的本地质量控制文档,如本地程序、支持质量控制流程和质量控制数字系统使用的模板,以符合赛诺菲全球流程
• Ensuring quality control processes supported by appropriate procedures are implemented locally and maintained, in line with Sanofi global requirements and regulatory. 确保由适当程序支持的质量控制流程在本地实施和维护,符合赛诺菲全球要求和法规
• Ensuring implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management) 确保质量控制数字解决方案(核心模型和本地)的实施和维护(包括数据管理和最终用户管理)
• Ensuring archiving of all QC documentation, in compliance with the Sanofi global requirements and regulatory. 确保所有质量控制文档的归档,符合赛诺菲全球要求和法规
• Ensuring training and support of end-users on QC processes and tools, in coordination with Sanofi global teams 确保与赛诺菲全球团队协调,对最终用户进行质量控制流程和工具的培训和支持
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs. 及时调查并解决其职责范围内的任何质量控制事件、问题或差异。实施调查结果和纠正预防措施(CAPA)的补救行动
• Providing support during regulatory inspections and audits by presenting QC processes and QC digital solution documents and records 在监管检查和审计期间提供支持,展示质量控制流程和质量控制数字解决方案文档和记录
• Leading initiatives for continuous improvement in QC processes and tools usage, in coordination with QC excellence team. 与质量控制卓越团队协调,领导质量控制流程和工具使用的持续改进计划
• Being representative of the factory in the CoPs led by the global, for the process in his/her scope, and if requested participating in the CoEs, and ensuring local communication. 作为全球领导的实践社区(CoP)中的工厂代表,负责其职责范围内的流程,如有要求参与卓越中心(CoE),并确保本地沟通
• Being representative of QC for the processes led by QMS team at factory level 在工厂层面作为质量管理系统(QMS)流程的质量控制代表
• Other Duties: Perform additional responsibilities as assigned by supervisor. 其他职责:履行领导交办的其他职责
任职要求
• Experience: At least 5 years of experience in quality control, preferably in a senior or managerial role工作经验:至少3年质量控制相关经验,倾向具有高级货管理岗位的经验。
• Soft skill: Proficient in interpersonal skill, presentation skill, communication skill, leadership abilities, teamwork influence,complex problem-solving skill and etc.,通用技能: 人际交往能力、沟通技巧、演讲能力、领导力、团队合作影响力和复杂问题解决能力等
• Technical skill: Managerial experience in pharmaceutical industry (operation, quality, OpEx,…), Proficient in quality control tools and techniques, including statistical process control专业技能: 药品生产企业管理经验(运营,质量,运营成本等), 精通质量控制工具及技术,包括过程控制统计学内容。
• Education: A Bachelor's degree in pharmacy, biotechnology, chemistry or related field
教育背景: 药学、生物技术、化学或相关领域的本科学位
• Languages: Proficient in listening, speaking, reading and writing, hold CET6 and above language certificate is preferred
语言要求: 精通英语听说读写,或持有大学英语六级或以上相关英文证书;
• Play to Win Behaviours: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致
工作城市:
深圳,招聘1人,详细地址:锦绣东路25号