1. To be responsible for tech transfer on behalf of MFG USP/DSP.
代表上游/下游生产负责技术转移；
2. Participate in the evaluation of new technology, new production
process and new production technology.
参与评估新工艺、新生产流程和新生产技术；
3. Make project BOM per required; Draft MPI and BPR per the process.
根据要求起草项目BOM；根据工艺要求写工艺规程和批记录；
4. As the representative of the production department, handle material qualification and supplier qualification.
作为生产部的代表处理物料确认和供应商确认；
5. As a representative of the production department, respond to quality audits from the administrative supervision departments and customers.
作为生产部代表应对来自行政监管部门和客户的质量审计；
Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.
根据需要参与公司的内部审计计划；能够担任跨职能团队的部门代表；
6. Deal with quality events in the production department, including deviations, change control, CAPA, EC, risk assessments, etc.
处理生产部的质量事件，包括偏差，变更，预防纠正措施，有效性检查，风险评估等；
7. Lead the equipment validation and Re-qualification work
主导设备验证和再确认工作。

Qualification 任职资格：

1. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
能够撰写详细的报告和总结，并展示注重细节的文档技能；
2. Communicate effectively and work professionally in a team environment.
善于在团队中进行有效的沟通和专业的工作；
3. Familiarity of computer-based systems.
熟悉计算机系统；
4. Oral and written communication skills in Chinese and English (Read, Write, Verbal).
良好的中英文读写和沟通能力；

5. Degree of junior college or above in Chemistry, Chemical Engineer, Life sciences or relevant background.
专科及以上学历，化学、化学工程、生命科学或者相关专业；
6. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs.
对于生物制药技术有一定了解，特别是单克隆抗体或者重组融合蛋白药物的工艺流程。