M&S-QC Specialist-Beijing at Sanofi Aventis US LLC

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

07 Jan, 26

Salary

0.0

Posted On

09 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Communication, Problem Solving, GMP Knowledge, Analytical Testing, Method Validation, Instrument Qualification, Lab Investigations, Quality Assessment, SOP Drafting, Technical Improvement, HSE Management, Energy Conservation, ICP-MS Experience, Documentation Practices, Safety Compliance, Team Collaboration

Industry

Pharmaceutical Manufacturing

Description

Job Information职位信息 Job title职位名称: QC Specialist/QC专员 Location工作地点： Beijing 北京 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, Medical devices, 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，清洁验证/确认和制药用水等样品； Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water. According to the protocol to carry out the method validation and instrument qualification, and can identify and raise up the defect in time. 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； 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. Take assigned 5S responsibilities. 5S分配任务。 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 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。 Pursue progress, discover extraordinary 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, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The QC Specialist will perform QC analyses in compliance with analytical methods and ensure timely execution of lab investigations and quality assessments. Responsibilities include sampling, method validation, and maintaining laboratory equipment while adhering to safety and documentation standards.