Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job title职位名称: QC Project Leader /QC 项目负责人

• Location工作地点： Hangzhou Site 杭州工厂

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。

General Mission职责概述

• Coordinate related stakeholder according to the site’s project master plan to ensure that the site’s LIMS system is deployed according to Sanofi’s system, ensuring compliance with quality, documentation and GMP and environmental/safety/health requirements
• LIMS系统按赛诺菲的体系部署，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
• Use digital tools to lead the optimization of laboratory processes and methods, improve laboratory regulatory compliance and test efficiency
• Assure all test perform according plan， assure all of instrument can support testing work,  assure all the analyses are carried out in compliance with analytical methods. Assure quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
• GMP以及环境/安全/健康的要求。
• Drafts standard operating procedures, analytical methods and instrumental validation/verification protocols, Assure the validation/verification carried out correctly.
• Training and support analyst in LIMS operation field

对检验员在LIMS操作领域的工作给予培训和支持

Activities具体职责

• Organize project team members to complete the deployment of LIMS projects according to the site plan.
• LIMS项目的部署。
• Ensures that the LIMS project architecture process for deployment meets the quality and digital requirements of Sanofi Group.
• LIMS项目架构流程符合赛诺菲集团的质量和数字化要求。
• Ensure that the LIMS project deployed meets the requirements of local regulations and GMP.
• LIMS项目符合当地法规和GMP的要求。
• Ensure that the LIMS project deployed can lead the quality control schedule and capacity planning to support the timely release of products and the adherence of the test’s execution to the committed standard times.
• LIMS项目能领导质量控制计划和产能规划，以支持及时释放产品并遵守承诺的标准时间执行测试。
• Ensure that the LIMS project deployed can define and maintaining the maintenance, qualification and calibration plans to ensure valid status of the lab equipment.
• LIMS项目能定义和维护维修、确认和校准计划，以确保实验室设备的有效状态。
• Ensure that the LIMS project deployed can handle sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan).
• LIMS项目能处理从取样到接收和发送到适当实验室的样品管理流程（包括按计划进行稳定性和 EM 样品管理）。
• Ensure that the LIMS project deployed can manage reference standards and reagents for the labs.
• LIMS项目能管理实验室的对照品和试剂。
• Implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management).
• QC 数字解决方案（核心模型和本地）（包括数据管理和最终用户管理）。
• Managing and training QC project team.
• QC 项目团队。
• HSE management is under the responsibility of the line Manager, he/she will provide a safe working environment for the employees. 

• Allocate appropriate and sufficient human, financial and material resources to ensure effective implementation of HSE programs (such as HSE event investigation, risk assessment identification and control, training, inspection, HSE action plan, leading safety program, PPE, HSE CAPAs follow up …… ) and management of all HSE issues.
  • HSE工作(比如HSE事件调查、风险识别和管控、培训、HSE工作计划、领先安全管理、PPE，HSE整改跟进……)得到有效实施和HSE问题得到有效解决。

• Other works assigned by QC manager.

上级安排的其他工作。

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

• Experience: Multi-national Company experience preferred。有跨国制药行业经验优先。
• Familiar to LIMS projects and proficiency in digital technology.

熟悉LIMS，熟练运用数字化技术。

• Experience in Project management。具有项目管理经验。
• Soft skill: Familiar to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation, team leading
  通用技能：熟悉现行GMP和法规，熟练应用办公电脑软件，良好的沟通协调能力，团队领导力。
• Technical skill: Familiar to CHP,EU & United state GMP, ICH regulation。
  专业技能: 熟悉中欧美药典，GMP，ICH等法规。
• Education: Bachelor’s degree above, Pharmacy or Chemical related field.
  教育背景: 本科学位以上，药学或化学相关专业。
• Languages: Good at English reading, writing, listening and speaking，be able to discuss the topics of quality and testing in English fluently.
  语言要求: 良好的英语听、说、读、写能力，可以流畅的用英语探讨质量和检验相关的话题。
• Play to Win Behaviors: 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

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。

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Strebe nach Fortschritt. Entdecke Einzigartiges.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.