无菌工艺模拟验证（DP生产）

理解并遵守公司的政策，尤其是知识产权保护。 Understand and comply with company’s policies, particularly in IP (intellectual property) protection. 负责DP无菌工艺模拟管理工作，撰写无菌工艺模拟策略文件，协助各DP车间完成无菌工艺模拟生产活动； Responsible for DP aseptic process simulation management, drafting aseptic process simulation strategy documents, and assisting various DP workshops in completing aseptic process simulation production activities; 负责各DP车间偏差管理工作，协助各车间完成偏差调查，把控进度，保证偏差报告质量； Responsible for deviation management in DP workshops, assisting workshops in deviation investigation, controlling progress, and ensuring the quality of deviation reports; 作为无菌工艺模拟话题和偏差事件的SME，负责与客户解释相关技术内容； Acting as the SME for aseptic process simulation topics and deviation events, responsible for explaining related technical content to customers； 组织无菌工艺模拟和偏差讨论会，协调各部门进行相关讨论； Organizing aseptic process simulation and deviation discussion meetings, coordinating relevant discussions among departments; 定期进行质量事件的数据分析，识别不良趋势，降低人为失误偏差的发生； Regularly conducting data analysis of quality events, identifying adverse trends, and reducing the occurrence of human error deviations; 协助完成变更、CAPA、风险评估、产品投诉等质量文件的管理工作，追踪相关任务按时完成； Assisting in managing quality documents such as change control, CAPA, risk assessments, and product complaints, and tracking the timely completion of related tasks; 指导人员完成TrackWise系统上质量文件的处理操作。 Guiding personnel in handling quality documents on the TrackWise system.

本科及以上学历，药学、微生物学、生物技术、化学工程等相关专业。 Bachelor’s degree or above in Pharmaceutical, Microbiology, Biological technology, Chemical engineering, or related major. 良好的沟通表达能力，较强的执行力和责任心； Good communication and expression skills, strong execution ability and sense of responsibility; 英文水平良好，能够撰写英文文件、进行英文沟通； Good proficiency in English, capable of writing English documents and conducting English communication; 具备无菌生产经验、偏差处理经验、无菌工艺模拟验证经验者更佳。 Experience in aseptic production, deviation handling, and aseptic process simulation validation is preferred.