工程验证QA

教育程度/经验：

1.本科以上学历，药学、化学或生物相关专业 Bachelor or above, major in pharmacy, chemistry, biological engineering or related;

2. 至少5年以上的设备、设施、计算机化系统验证管理经验，有生物制药经验优先； At least 5 years of equipment, facility, utility, and Computerized systems qualification and validation experience, biological pharmaceutical experience is preferred;

3. 熟悉cGMP、FDA、欧盟等相关法规在质量管理方面的要求。 Familiar with cGMP, FDA, EMA and other related rules and regulations required in quality management

技能要求：

1. 具备快速的学习能力；良好的沟通协调能力；优秀的逻辑与决策能力。 Good learning agility；Good communication and coordination；Good logical and decision ability

2. 良好的英语表达技能 Good English presentation skill

岗位职责：

1. 负责生产、工程、验证、计算机化系统相关文件的审批（例如：工单、维护计划等）；Responsible for approving documents related to production, engineering, validation, and computerized systems (e.g., work orders, maintenance plans, etc.);

2. 负责验证、工程和计算机化系统相关的质量事件的处理；

Handles quality incidents related to validation, engineering, and computerized systems;

3. 负责生产、工程、验证、计算机化系统的质量监控和管理。

Oversees quality monitoring and management of production, engineering, validation, and computerized systems.

4. 负责CB/DS生 产，工程，验证，DI 相关文件的审核

Responsible for reviewing related documents including CB/DS, Engineering, Qualification/Validation, DI

5. 开展虫害控制的质量管理 Quality management on pest control

6. 支持WBS工作 Support WBS projects

7. 领导安排的其他工作。Other work assigned by the leader.