DP 14-PFS Function Leader

JOB RESPONSIBILITY

1. 01

   负责制剂生产技术转移。撰写相关的生产文件。 Responsible the tech-transfer of DP manufacturing. Draft relevant manufacturing documentations.

2. 02

   了解cGMP法规要求。 Understand the requirements of cGMP regulation.

3. 03

   了解预灌封注射器的基本知识和相关的法规要求。 Understand basic knowledge of pre-filled syringe and relevant regulatory requirements.

4. 04

   参与车间的生产活动 Participate in the manufacturing activities;

5. 05

   熟悉隔离器设备的操作及工作原理 Familiar with the operation and working principle of isolator

6. 06

   熟悉衡器、一次性混匀系统、蠕动泵、完整性测试仪等配液相关生产设备的操作和工作原理。 Familiar with the operation and working principle of balance, single-use mixing system, peristaltic pump, integrity tester and other related equipment.

7. 07

   熟悉目检/半自动/自动灯检设备的操作及工作原理 Familiar with the operation and working principle of MVI/ Semi-AVI/ AVI

Job Requirements： 学历要求：985/211院校硕士及以上学历 Master's degree or above from a 985/211 university. 专业方向：药学，制药工程、生物等相关专业； Major: Pharmacy, Pharmaceutical Engineering, Biology, or other related disciplines.