M&S-Associate Engineer, Inoculation-Shenzhen

Start free →

Or apply yourself on the official page →

About the role

Job Information 职位信息 Job title职位名称: Associate Engineer, Inoculation 接种助理工程师 • Location工作地点： Shenzhen, Guandong Province, China 中国广东省深圳市 • % Remote working and % of travel expected 远程办公和出差的概率：N/A • Job type工作类型: Full time全职 • Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部 About the job 工作职责 Our Team 我们的团队： The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools. 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。 • Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.确保赛诺菲在中国运营的所有产品的分销和营销活动符合赛诺菲质量政策、质量标准及适用的法规要求。 • Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.管理质量流程并执行程序中定义的质量控制活动，特别是根据现行GSP/GDP法规建立的相关活动。 • Provide strong quality support to innovation and business initiatives, including digital transformation projects. 从质量角度为创新和业务举措（包括数字化转型项目）提供有力支持。 • Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements. 在整个组织中推广质量文化和质量思维，确保符合赛诺菲全球标准和中国本地法规要求。 Main responsibilities 职责描述： 1. Team management and Personal development 团队管理及人员发展 • Pay attention to health,safety and production environment requirements, and improve and adjust accordingly if necessary • 关注健康、安全及生产环境要求并在必要时做出相应改善及调整。 • Responsible for the inoculation steps in the production of influenza stock solution, and complete all related operations of virus inoculation preparation, inoculation and cultivation. Then the inoculated chicken embryos and eggs are cultured to multiply the virus and delivered to the harvesting group; daily cleaning and disinfection, material preparation and environmental monitoring are carried out. Comply with quality and health, safety and environment regulations in production operations, ensure safe and effective production operations, and provide technical support to the team and other departments. • 负责流感原液生产的接种步骤，完成病毒接种液的制备、接种和培养的所有相关操作。然后将已完成接种的鸡胚蛋经过培养使病毒增殖交付到收获组；并进行日常清洁消毒、物料准备和环境监控等。在生产操作中遵守质量及健康安全环境守则，确保安全有效地进行生产操作，为团队及其他部门提供技术支持。 2. Work Delivery 工作交付 • Ensure staff training and qualification according to the requirements; Ensure the supply of material and manpower deployment； • 根据要求确保个人的培训及资质；确保物料供应； • Participate in the production operation of the inoculation process, ensure safe, compliant, and effective production operations, and deliver products on time, quality and quantity; • 参与接种工序的生产操作，确保安全、合规、有效地进行生产操作，并按时按质按量交付产品； • Ensure production activities according to related procedure, standard operating procedures and batch records, supervision and inspection records of area. • 确保生产活动根据相关工艺规程、标准操作规程及批记录进行，按时填写和提交区域记录和批记录。 • Ensure data integrity in production activities meets requirements; • 确保生产活动中的数据完整性符合要求； • Participate in the writing and execution of all validation plans/reports in this group. • 参与本组所有验证方案/报告的编写和验证的执行。 • Provide/enter relevant production data (MES, SAP, CMS, One LIMS,SMS2.0, SPCetc.) on time; • 按时提供/录入相关生产数据 (MES, SAP, CMS ,One LIMS,SMS2.0，SPC等)； • Timely report and assist in resolving issues that arise during production; Responsible for writing relevant technical documents; Participate in investigating deviations that occur in the production field; Timely completion of CAPA; • 及时汇报并协助解决生产中出现的问题；负责相关技术文件的编写；参与调查生产领域中发生的偏差；及时完成CAPA； • Responsible for receiving production materials

View the official posting →