Job Information职位信息 Job title职位名称: QA Specialist QA专员 Location工作地点： Beijing, China 中国北京 % 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： 主要职责 •Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements 确保其范围内的活动按照适用的监管要求进行 • Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations 确保符合药品生产质量管理规范 （GMP） 和其他相关法规 • Conducting regular audits of production processes to identify and address potential quality issues 对生产流程进行定期审计，以识别和解决潜在的质量问题 • Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor 与生产部门密切协作，确保在整个产品生命周期内保持质量标准；强烈建议位于车间 • Managing and resolving quality-related issues in a timely and effective manner 及时有效地管理和解决质量相关问题 • Monitoring and analyzing quality performance metrics, implementing corrective actions as needed 监控和分析质量绩效指标，根据需要实施纠正措施 • Leading root cause analysis investigations for quality incidents and implementing preventive measures 领导质量事故的根本原因分析调查并实施预防措施 • Participating in internal and external audits and regulatory inspections providing support and documentation 参与内部和外部审计和监管检查，提供支持和文件 • Reviewing batch records and associated documentation 审核批记录和相关文件 • Developing and implementing risk management strategies to mitigate potential quality issues 制定和实施风险管理策略，以缓解潜在的质量问题 • Fostering a culture of quality and continuous improvement across the organization 在整个组织内培养质量和持续改进的文化 •Participate in deviation, complaint, and change control processes, demonstrating high independent judgment in timely identification, investigation, and resolution of deviations and complaints that may impact product quality; participate in initiating corrective and preventive actions, support CAPA implementation and verify CAPA effectiveness.
Reviewing batch records and associated documentation. 参与偏差，投诉和变更流程，在及时识别、调查和解决可能影响产品质量的偏差和投诉方面，表现出较高的独立判断力；参与发起纠正和预防措施，支持CAPA的实施并检查CAPA的有效性。 •Review batch records and associated documents to ensure accuracy and compliance; draft and revise quality-related procedures and standard operating procedures(SOPs). 审核批记录和相关文件,起草修订质量相关规程。 •CMO management : Conduct on-site inspections of the CMO CMO 管理：对CMO进行现场检查 •Complete product quality review to ensure that PQR is completed in a timely manner in accordance with the corresponding procedures and GMP requirements.
完成产品质量回顾，确保PQR 按照相应的程序和GMP