Effectively producing intermediates and drug substances by operating complex processing
equipment independently according to the Plant Master Procedure (i.e. PMP) in compliance
with SOP, HSE, and other guidelines.
在符合 SOP, HSE 和其他规定的基础上,按照工厂主操作规程,独立操作复杂的工艺设备进
行有效的医药中间体和最终产品的生产
1. Prepares equipment trains and other production variables according to the needs of the
assigned process with little or no supervision.
能够根据指定工艺流程的需要,基本可以独立准备设备链和其他生产所需的事项
2. Executes the daily operations for the assigned process while following the PMP and
maintaining compliance with SOP, HSE, and other guidelines
对指定工艺流程执行日常操作,确保符合 PMP,SOP,HSE 以及其他相关规定
3. Can independently operate all routine process equipment and systems
能够独立操作所有常规生产设备和系统
4. Understands and carries out waste management activities in accordance with internal &
external regulations (Exhaust air, effluent, liquid & solid waste)
根据内外部规章制度,了解并独立进行废弃物处理(废气,废水,废液和固废)
5. Reassembles & cleans most process equipment with little or no supervision
基本可以独立进行大部分设备的清洗和重置
6. Record all actions in batch record
在操作记录本上及时记录所有操作
7. Actively contributes to keeping the plant clean and properly maintained
积极参与并保持良好的车间维护和清洁
8. Provide equipment and process troubleshooting ideas
在设备和工艺出现问题时能提供解决建议
9. Provide process and safety improvement suggestions
提供工艺和安全改进建议
10. Gives guidance to less experienced operators regarding equipment set-up, batch
execution activities, and equipment cleaning.
在设备准备,生产批次执行和设备清洁方面,对新进员工提供指导
11. Can carry out assigned special tasks (e.g. process steering control analytics)
可以执行特定的任务(如: 中控分析)
12. Can lead operating team as needed
如有需要,可以领导操作团队
13. Various responsibilities in accordance to GMP HSE responsibility lists of the LSC
根据 GMP/HSE 要求,承担其他相关职责