GMP制剂技术转移研究员-北京

岗位职责：
Responsibilities:
1. 起草转移项目或重复生产项目批记录，生产时提供技术支持；
Write the batch records for the transferred projects or re-manufactured at GMP area and supply technical support to operators.
2. 起草NDA项目技术转移方案和报告；
Write the technology transfer protocols and reports for NDA projects.
3. 起草NDA项目转移批或工程批记录；
Write the transfer batch records for NDA projects, including engineering batch records.
4. 起草工艺验证方案、报告和批记录；
Write the protocols, reports and batch records for process validation.
5. 与客户进行技术沟通；
Communicate technology with the related clients.
6. 完成其他相关工作。
Execute other related tasks.
任职资格：
Qualification:
1. 药物制剂、制药工程或相关专业本科以上学历；
Bachelor’s degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors
2. 两年以上制剂研发经验；
At least 2 years’ experience in formulation development.
3. 了解相关制药法规和指导原则，如《中华人民共和国药品管理法》和GMP法规；
Understand the relevant pharmaceutical laws, regulations and guides, such as “The Drug Administration Law of the PRC” and “Good Manufacturing Practices”
4. 熟悉制剂研发过程，掌握关键口服固体制剂设备的性能；
Familiar with the procedure of formulation development, and master the performance of key equipment used for OSD.
5. 具有工艺问题分析能力、设计方案能力、判断能力、操作能力、与他人沟通能力；
Have ability to analyze process problems, design protocols, judge, operate and communicate with others.
6. 具有独立解决产品工艺问题的能力；
Have ability to solve process problems independently.
7. 熟悉电脑文档操作。
Familiar with computer documentation operation.