现场QA(DS区域）

Job Responsibility *

1. 01

   负责DS/DP产品生产过程中的现场质量监控和管理 Responsible for site quality monitoring and management during DS/DP product manufacturing

2. 02

   负责相关质量文件的起草、审批 Responsible for drafting and reviewing/approving related quality document

3. 03

   负责DS/DP生产，工程，验证，DI 相 关文件的审核 Responsible for reviewing related documents including DS/DP, Engineering, Qualification/Validation, DI

4. 04

   支持完成DS,DP 批放行相关文件的准备、检查、审核过程 Support completion of preparation, inspection, review process for DS, DP batch release related documents

5. 05

   负责PFD, 主批生产记录（MBR）和批生产记录（BPR）的审核； Responsible for reviewing PFD, MBR, and BPR;

6. 06

   负责处理生产过程中偏差、变更等质量事件； Responsible for handing deviation, change control and other quality events during production

7. 07

   参与项目相关 问题的协调与处理；如兼职QA FL Participate in the coordination and treatment of project related issues, such as part time QA FL

8. 08

   参与公司内审和外审相关工作； Participate in enterprise internal and external audit related work;

9. 09

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

10. 10

    支持MFG22 工厂的GMP 运营 Support GMP running on MFG22

11. 11

    支持 WBS工作 Support WBS projects

12. 12

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

教育程度/经验Education background/ Experience

1. 01

   药学、化学、生物工程等相关专业，本科及以上学历； Bachelor or above, major in pharmacy, chemistry, biological engineering or related;

2. 02

   至少2年以上质量管理经验，有生物制药经验优 先； At least 2 years of quality management experience, biological pharmaceutical experience is preferred;

3. 03

   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 其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)

4. 01

   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

5. 02

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

6. 03

   周一至周五 08:30-17:00工作段时间；如有工作业务需要，安排时间以 达成工作任务以及紧急情况的处理 08:30 to 17:00 working time from Monday to Friday; and Any time can be planned if any business required