- 招聘人数:1 人
- 到岗时间:不限
- 年龄要求:35周岁以上
- 婚况要求:已婚
1. Responsible for R & D quality management (CMC & clinical research) Coordinate with internal external parties. 全面负责研发质量管理工作(包括药学和临床二部份质量体系),明确分工,合理安排,及时协调部门内外各项工作关系。
2. Ensure the research development activities are performed in compliance with the regulatory requirements . 负责研发合规。
3. Set up the R&D quality management system draft the quality management system documents (manuals, procedures)
guide monitor the implementation of the system.负责起草和修订研发质量管理制度,编写质量管理体系文件(手册、程序)并指导、督促制度的执行。
4. Guide monitor the quality of other departments. 指导和监督其它部门的质量工作。
5. Assist EP registration FDA registration of the products. 协助EP,FDA产品注册工作。
6.Performs other duties or special projects as required or as assigned.完成上司交给的其它工作。
职位要求:
任职资格
1. Bachelor degree or above in Pharmacy or related disciplines. At least 5 years of related experience in
Pharmaceutical industry. 本科及以上学位,硕士优先,药学相关行业5年以上从业经验;
2. Familiar with drug research workflow with experience in R&D quality management 熟练药品研发工作流程,有研发质量控制经验;
4, Good comm of both spoken written English is preferred 良好的英文沟通能力优先;
5, Good presentation communication skills, strong learning ability, strong sense of responsibility, hard working
team player able to work under pressure 良好的语言表达与沟通能力,学习能力强、责任心强、能吃苦耐劳、有较强的团队合作精神能承受工作压力;