偶联原液生产审计专家

Role and Responsibility:

Lead and organize XDS PLI Readiness Program, ensure the success of regulatory inspection

负责组织协调组织偶联原液生产部的官方审计准备活动，确保成功通过官方审计的成功

Responsible for XDS client audit management, coordinating all necessary activities across each team prior to, during and post audit,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。

Act as SME during audit for topics within the scope

审计过程中作为SME负责相关主题内容的讲解

Train and coach SME to continuously improve audit capability in XDS;

培训辅导部门内 SME持续提升整体迎检能力；

Monitoring FDA 483 publish and coordinate the internal gap assessment, ensure the potential risks are well controlled

跟踪FDA483的发布，并协调偶联原液生产部内部的差距分析，确保潜在风险提前控制

Regulation Intelligence: act as POC on behalf of XDS, and lead the gap assessment

作为偶联原液生产部的法规解读POC， 主导法规差距分析

Analyze audit performance to identify adverse trends and/or potential improvement opportunities; coordinate with cross department to mitigate the potential risks.

定期分析审计数据分析，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

Other tasks assigned by supervisor主管交代的其他任务

Requirement:

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

At least 5 years' experience in manufacturing and/or QA related in biopharmaceutical industry

至少5年以上医药及生物行业生产和质量相关工作经验

Familiar with FDA/China/EU and ICH GMP requirements

熟悉FDA/中国 /欧盟法规及 ICH等 的要求

Background with ADC manufacturing well is preferred

熟悉ADC生产工艺优先

Experience with regulatory inspection, e.g. FDA, EMEA inspection is preferred

有FDA, EMEA 官方检查准备和迎检经验者优先

familiar with Microsoft office, fluent English listening, speaking, reading and writing skill

熟悉office办公软件操作，良好的英语听说读写能力

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