M&S-Associate Manager of Batch Release-Beijing

Job Information职位信息

Job title职位名称: Associate Manager of Batch Release

• Location工作地点： Beijing
• % 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
• Site/Unit 区域/事业部：M&S China中国制造与供应事业部

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。

• Keep on developing the quality system, and establish or update the related sop according the globalquality standard / cGMP and other local requirements together with other departments. cGMP 以及地方法规要求建立或更新质量保证体系，配合其他部门对
• Ensure the cGMP compliance of the calibration, utilities, systems, production processes (raw materials, in process product, finished products) and control procedures. GMP 符合性；
• Act as Authrized Person to perform batch disposition and material release.
• Support significant deviations investigation.
• Participate self-audit , global audit and regulatory inspection to improve the site GMP compliance.参与自检，GQA 审计和内外部审计，不断改进工厂的 GMP 符合性。
• Ensures quality risks are properly managed (identification, assessment, control, communication).确保质量风险得到适当管理（识别、评估、控制和沟通）
• Lead Mars project. Define user requirements, organize training, ensures acceptance and deployment of the solution from a user perspective. Coordinates and manages all user activities主导Mars项目。定义用户需求，组织培训，代表用户保证方案的部署和实施。协调管理其它项目成员的工作。
• Other task from QO manager其他质量经理分配的任务。
• Take the responsibility of HSE in Quality承担质量部HSE相关职责

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: At least 5 years’ experience in sterile process, batch disposition as quality assurance. 工作经验:，至少 5 年以上无菌 QA 现场管理, 批放行工作经验。
• Soft skill: Good communication, able to burden pressure. Think strategically. Make decisions. Good leadership 用技能: 良好的沟通能力，能够耐受压力。战略思维，果敢决策，领导能力
• Technical skill: professional knowledge of quality systems in pharmaceutical industry, experienced in domestic and international GMP inspection, EMA or FDA inspection is preferred 专业技能:制药行业质量体系相关知识，国内外审计经验，有欧盟审计经验优先
• Education: At least a bachelor’s degree in pharmacy or chemistry or biology 教育背景: 至少药学或化学或生物学或相关专业大学本科学历
• Languages: Good communication and writing in English 英语沟通和书写熟练
• 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。