M&S-QC Specialist-Beijing

Job Information职位信息

Job title职位名称: QC specialist- Sample Testing /QC专员-样品检测

• 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：

To carry out QC analyses in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.

按照分析方法/方案/标准进行理化实验，遵守良好文件记录和GMP以及环境/安全/健康的要求。

Specifically, 具体为

According to the test methods/protocols/specifications to carry out analytical testing for samples of semi-finished products, finished products, API, excipients, packaging material, cleaning validation/verification and pharmaceutical water, etc.. /方案/标准对半成品，成品，原辅料，包材，医疗器械，制药用水，清洁验证/确认等样品，执行分析检验； Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water.
Lab related SAP data maintenance. SAP数据维护； Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
Maintain the availability of test equipment together with supplier and maintenance technician.
Carry out the maintenance of laboratory equipment according to the established schedules and maintain accurate records and archive.
(Assist and) draft of work related SOPs, testing record template, qualification protocols/reports of the analytical instruments and the analytical methods. Perform the qualification work. /报告及分析方法，并进行相关验证工作； Print and manage lab related logbook. logbook。 Assist GAP analyses between global requirement and local authority standard.
Pay attention on the number of available reagents, column, reference standards and other testing relates consumables ensure proper amount can be used. Manager archives of columns.
Provide technical support to official testing.
Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations. GSP）执行医疗器械相关活动。 Take assigned 5S responsibilities. 5S分配任务。 Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations. 依据现行经营管理规范（GSP）执行医疗器械相关活动 Engaged in the lab continuously improvement of technical and management purpose. Advocate and execute the SMS concept and practice.
Execute other works which is assigned by superior.

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。

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

About you 任职资格:

• Experience: Have Pharmacy GMP lab working experience.

具有药厂GMP实验室工作经验

• 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.

教育背景: 化学、生物化学、微生物学、药学等相关专业

• 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。