M&S-QC Key Users-Beijing

Job Information职位信息

Job title职位名称: QC Key Users/QC关键用户

• Location工作地点： Beijing 北京
• % Remote working and % of travel expected 远程办公和出差的概率：3%
• Job type工作类型: Full time全职
• Site/Unit 区域/事业部：Manufacturing & Supply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：

In General, responsible for QC software system management, quality system establishment and maintenance, on-site inspection and feedback. Ensure QC quality system compliant and high efficient, supporting activities meet SOP requirement and testing needs. Establish and maintain SMS mentality across unit; run SMS projects utilizing lean tools and methodologies.

职责概述：负责QC软件系统管理，质量体系流程的搭建和维护，现场审计及后续回复，确保QC质量体系合规高效，支持各项活动符合SOP要求及检验需求。建立和维护SMS思想，运用SMS工具和方法，执行SMS项目。

Specifically, 具体为

• Ensure periodically reviewing QC quality system document and executing system document gap analysis. Use risk assessment to ensure QC quality system compliance and meeting business need.
• QC质量体系文件，及时执行体系文件差距分析，使用风险评估的方式确保QC质量体系合规的同时满足相关业务需求
• 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
• (CAPA) 实施补救措施。
• Ensure QC instrument and facility compliance and meeting lab business need.
• QC仪器、硬件设施管理合规且符合实验室业务需求。
• Ensure training management compliance and meet lab business needs, Ensure QC management
• Responsible of internal & External inspections for QC field and afterward actions. Supervise related CAPAs  being implemented in time.
• QC区域的内外部审计及后续的工作并执行或监督相关纠正预防措施的及时执行。
• Support or own related new Projects.
• Leading initiatives for continuous improvement in QC, in coordination with QC excellence team

HSE responsibilities HSE职责：

• Proactively response to HSE management works to prevent each type of accident, and proactively propose HSE related feedbacks or advices.

积极配合HSE管理工作，防止各类事故的发生,积极提出HSE 相关反馈或意见。

• HSE coordinator is responsible of organize or execute each type of HSE related work according to HSE department requirement.

HSE协调员负责根据HSE部分要求组织或执行各项HSE相关工作。

Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

• Actively propose energy-saving projects

积极提出节能方案

• Support the development of energy-saving projects and give positive feedback

支持节能项目的制定，积极反馈意见

• Participate in and implement energy-saving projects

参与并实施节能项目

• Participate in internal audit of energy management system

参与能源管理体系的内部评审

Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展

•  Actively propose energy-saving projects

积极提出节能方案

•  Coordinate and support the development of energy-saving projects and give positive feedback

协调并支持节能项目的制定，积极反馈意见

• Coordinate and participate in the implementation of energy-saving projects

协调并参与节能项目的执行

• Participate in internal audit of energy management system

参与能源管理体系的内部评审

About you 任职资格:

• Experience: Have Pharmacy GMP working experience.

具有药厂GMP工作经验

• Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.

通用技能: 沟通，问题解决, 善于解决问题的能力和主动性。

• Technical skill: a good knowledge of Chinese and international GMP, DI are required.

专业技能: 要求熟悉中国和国际GMP，数据完整性要求。

• Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. bachelor degree at a minimum

教育背景: 化学、生物化学、微生物学、药学等相关专业学士及以上学位

• Languages: Good at English writing, reading, listening and spoken

语言要求:英语听说读写良好

• 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。