主要职责/Key Responsibilities：
1. 根据内部和外部要求编写和评审生产过程和系统验证文档。
Write and review validation documentation against production processes and systems in compliance to internal and external requirement.
2. 管理与新产品开发和现有生产过程、系统和控制相关的验证主计划和相关报告。
Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.
3. 作为验证方案管理者，管理方案的执行，确保其及时且经济高效地完成。
Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion.
4. 评估验证方案执行的验证结果并在最终报告中总结验证结果。
Evaluate validation results of validation protocol executions and summarize validation results in final reports.
5. 对变更管理文档执行验证评估，包括但不限于文件更改、系统更改和过程更改。
Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.
6. 计划、组织日常工作并管理好优先次序，以在规定的时间表内完成工作任务。
Plans, organizes, and prioritizes own daily work routine to meet established schedule.
7. 跟踪和报告验证项目的验证进度。
Track and report validation progress of validation projects.
8. 为经验不足的员工提供指导。
Provides guidance to less experienced staff.
9. 配合验证过程的内部和外部审核准备工作并做合理应对，确保审核工作有序有效的开展；推进验证的改进工作。
Cooperate with the preparation of internal and external audit of validation activities and make reasonable responses to ensure that the audit is carried out in an orderly and effective manner; promote the improvement of the validation program.
10. 完成上级临时交办的任务。
Complete tasks temporarily assigned by superiors.

任职资格/Job Requirements：
1. 资格证书/Certificate：
无要求。 No requirements.
2. 外语技能/Foreign Language Skills：
熟练的英语口语和书面报告能力Proficient English speaking and written reporting skills
3. 计算机软件技能Software Skills
熟练掌握WORD, EXCEL, POWERPOINT等办公软件
Proficient in WORD, EXCEL, POWERPOINT and other office software
4. 工作经验或专业背景/Work Experience or Professional Background：
2-5年相关工作经验，对指定职能领域有较好的了解。2-5 years of related work experience with a good understanding of specified functional area.
5. 教育背景/Education Background
学士及以上，医药、工程、机械等相关专业Bachelor’s degree or above, Medicine, engineering, machinery and other related majors
6. 其它要求/Others：
能熟练起草安装验证IQ/运行确认OQ/性能确认PQ方案和报告
Ability to draft IQ/OQ/PQ protocol and report proficiently