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

Job Information职位信息

Job title职位名称: QC Analyst Physico Chemistry

•    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
1.    According to the test methods/protocols/specifications to carry out analytical testing for samples of semi-finished products, finished products, API, excipients, packaging material, Medical devices, cleaning validation/verification and pharmaceutical water, etc.. 
按照分析方法/方案/标准对半成品，成品，原辅料，包材，医疗器械，清洁验证/确认和制药用水等样品；
2.    Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water. 
负责原料、辅料、包装材料、进口半成品、清洁验证取样和制药用水的取样；
3.    According to the protocol to carry out the method validation and instrument qualification, and can identify and raise up the defect in time.
依据方案执行方法验证或设备验证，执行过程中需能够识别到方法或设备自身缺陷并及时上报。
4.    Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
确保样品及时检验。执行实验室调查以及产品质量评估；
5.    Maintain the availability of test equipment together with supplier and maintenance technician. 
与设备厂家及维护工程师一起确保检验设备的正常状态；
6.    Carry out the maintenance of laboratory equipment according to the established schedules and maintain accurate records and archive. 
按计划对实验室仪器进行维护并准确记录和存档；
7.    (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. 
（协助）编写工作相关的标准操作规程、检验记录模板，仪器确认方案/报告及分析方法，并进行相关验证工作；
8.    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.
关注可用的试剂、色谱柱、对照品及其他检测相关耗材确保有足量可用。并管理色谱柱档案。
9.    Take assigned 5S responsibilities.
执行5S分配任务。
10.    Engaged in the lab continuously improvement of technical and management purpose. Advocate and execute the SMS concept and practice.
参与实验室管理及技术的持续改善活动。倡导和实施赛诺菲管理系统。
11.    Execute other works which is assigned by superior.
执行上级分配的其他工作。

12.    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。

13.    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
•    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 more than 3 years of experience. 
具有3年以上药厂GMP实验室工作经验。
•    Soft skill: Communication, problem solving oriented. Good problem-solving skills and initiative.
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. Experience in ICP-MS use and maintenance is preferred.
专业技能: 要求熟悉中国和国际GMP，数据完整性要求。具有ICP-MS使用和维护经验者优先。
•    Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. Bachelor degree or above.
教育背景: 化学、生物化学、微生物学、药学等相关专业。本科及以上学历。
•    Languages: Good at English writing, reading, listening and spoken
语言要求:英语听说读写良好
•    Take The Lead Behaviours：Aim Higher、Act for Patients、Be Bold and Lead Together
引领前行行为：更高目标、以患者为本、勇于创新、共同领导

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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Pursue Progress. Discovery Extraordinary.

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.