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 global quality standard / cGMP and other local requirements together with other departments. 依据全球质量政策、标准、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 标准操作规程进行不断改进升级和完善； • Ensure the cGMP compliance of the calibration, utilities, systems, production processes (raw materials, in process product, finished products) and control procedures. 保证相关的校准、设施、系统、生产工艺（原料、半成品和成品）以及质量控制的 GMP 符合性； • Act as Authrized Person to perform batch disposition and material release. 作为质量受权人的转授权人进行批次处置和物料放行。 • Support significant deviations investigation. 支持重大偏差的调查。 • 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

• 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 通用技能: 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 语言要求: 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