Be responsible for XDS audit management, coordinating all necessary activities across each team prior to, during and post audit, track CAPA completion 负责XDS整体审计管理，协调各团队资源支持审计前准备，审计执行以及审计后的回复及整改跟踪。 Organize regular walk-throughs in XDS; address findings and rectify issues detected; 日常walk through组织，发现项整改 Analyze quality data to identify adverse trends and/or potential improvement opportunities; coordinate with cross department to mitigate the potential risks. 分析质量数据识别不利趋势和潜在的改善机会，组织相关部门落实跟踪改善计划和行动； Participate in deviation investigation and report review, ensure appropriate CAPA is in place 参与偏差调查以及调查报告审核，确保合适的纠正预防措施制定，如有必要，支持和客户的沟通 Join Change Control Review Board on behalf of CCRB, ensure appropriate impact assessment is performed and mitigation in place prior to change execution, support communication with clients if needed. 作为XDS代表担任部门变更委员会成员，确保变更在执行前获得充分的影响评估并识别必要的措施，如有需要，支持和客户的沟通； Participate in observing and reviewing critical operational steps, ensure the pre-defined procedures and processes are well followed during day-to-day operation 参与生产关键操作步骤的现场监控和复核，确保生产按照既定的流程和工艺参数执行生产活动 Coordinate internal and/or cross function discussions to resolve quality-related issues; 协调团队内部或跨团队quality相关问题讨论解决； Support XDS GMP document management 支持XDS GMP 文件管理 Support XDS GMP training management 支持XDS GMP 培训管理 other tasks assigned by supervisor 主管安排的其他任务

Education background教育程度： Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field. 化学、生物化学、生物学、药学本科及本科以上学历。生物工程或相关领域。 Experience 经验： At least 3+ years’ working experience in large molecule drugs or conjugated drugs’ manufacturing or quality management, have certain experience in project management and team management. 具有至少3年以上的大分子药物或偶联药物生产或质量管理经验，并具有一定的项目管理和团队管理经验。 Perfect for knowing ADC manufacturing well 熟悉ADC生产工艺优先 Good communication, and logical thinking skills, execution ability, with certain ability to handle pressure 良好的沟通、逻辑思维能力及执行力，具有一定的抗压能力。. Excellent English listening, speaking, reading and writing skill, good at meeting organization and document writing ability 流利的英文听说读写能力，擅于会议组织和文件撰写。 Strong ownership, learnability, teamwork spirit and positive attitude 责任感强，学习意愿和能力强，具有团队协作精神，及积极向上的态度