工程和验证QA

教育和基本技能要求 Education and techinical requirements：

1.药学、化学、生物工程等相关专业，本科及以上学历。

Pharmacy, Chemistry, Biological Engineer and other related majors, BS degree or above.

2.至少5年以上药企质量保证工程和验证经验，有生物制药经验优先。

Minimum 5 years' experience in QA related to Engineering and validation of pharmaceutical companies, biopharmaceutical experience is preferred.

3.具有生物制药企业运行和/或无菌产品生产相关经验。 掌握无菌保障技术相关验证，如湿热灭菌、器验证、无菌工艺模拟等

Experienced in operation of biopharmaceutical facilities and/or aseptic product manufacturing. Master of aseptical technology related qualification and validation requirements, such as autoclave qualification, sterilization programs, isolators, and APS.

4.熟练运用办公软件，如Word、Excel、Power Point等。

Advanced computer system and software skills-Word, Excel, Power point etc.

5.具有良好的英语听说读写能力。

Well English reading, writing, speaking/comprehension skill.

6.熟悉AI制药相关的法规要求。 Know AI related guidance

7. 具备精益改善思维，能在合规的前提下，优化并提高工作效率 Ability of optimization and improvement of woking efficiency.

工作职责 Responsibility：

1.负责生产、工程、验证、DI、计算机化系统相关文件的审批

Responsible for reviewing/approving related documents including MFG, Engineering, Validation, DI and computerized system.

2.负责验证、工程、DI和计算机化系统相关的质量事件的处理

Responsible for handing quality events during Validation, Engineering, DI and computerized system.

3.负责客户审计或官方审计中关于验证、工程、DI和计算机化系统的部分

Responsible for the validation, engineering, DI and computerized system parts of customer audit or official audit.

4.负责生产、工程、验证、计算机化系统的质量监控和管理；

Responsible for quality control and management of MFG, Engineering,Validation and computerized system.

5. 和其他基地以及和总部质量团队一起，优化验证策略和DI策略，满足法规需求。

Responsible for validation and DI strategy improvement to align with other sites and coroperate departmets

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