M&S-QC Specialist-Beijing

Job Information职位信息

Job title职位名称: QC Specialist/QC分析专员

•    Location工作地点： Beijing 北京
•    % 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：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 Pharmaceutical analysis technical support in Physical chemistry, biochemistry, microbiology including but not limited to method validation/verification/transfer, HA authority technical support,  testing in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.
在理化，生化，微生物方向提供药物分析技术支持，包括但不限于方法验证/确认/转移，官方机构技术支持，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.    Prepare method familiarisation, validation, verification, and transfer protocols in accordance with project timelines, execute testing per protocol, and generate corresponding reports. Draft method and specifications. 
依据项目进度撰写方法熟悉、验证、确认、转移方案并依据方案进行试验并出具对应报告。起草方法及质量标准。
Attend project meetings, oversee lab deliverables, manage timelines/budgets, and ensure cost efficiency.
参加项目会议，管控实验室项目进度，节点跟踪及预算，确保资源高效利用。
2.    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.. 
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，制药用水，清洁验证/确认等样品，执行分析检验；
3.    Take assigned 5S responsibilities.
执行5S分配任务。
4.    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
5.    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。
6.    Execute other works which is assigned by superior.
执行上级分配的其他工作。

7.    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。

8.    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 method development/validation/transfer experience in biologic drug product.
经验：从事过2年以上生物药方法开发验证转移工作。
•    Soft skill: Good at communication, problem solving oriented, strong self-learning capability.
通用技能: 善于沟通，问题解决,自主学习能力强。
•    Technical skill: Have Pharmaceutical analysis experience in Physical chemistry, biochemistry or Microbiology, preferably in biochemistry.
专业技能：具有生化或微生物药物分析实验工作经验，生物化学分析方向优先。
•    Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. Bachelor degree or above. Master degree is preferred. Candidates from domestic top-tier universities or with study-abroad experience in English-speaking countries will be given preference.
教育背景：化学、生物化学、微生物学、药学等相关专业。本科或以上学历（硕士优先）。优先考虑国内外顶尖院校毕业生。
•    Languages: Good at English writing, reading, listening and spoken.
语言要求：英语听说读写良好。
•    Play to Win Behaviours: 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。