Responsibility主要职责

·         参与新厂房的建设，如文件准备、现场监工等；

·         参与新设备确认，特别是PQ；

·         协助技术工程师，将产品转移至临床或商业生产；

·         协助所有PPQ相关活动、RA、协议、培训、执行、报告；

·         协助技术工程师进行清洁验证的相关工作；

·         参与解决生产过程中的工艺问题；

·         确保满足所有适用的安全、健康和环境要求，以符合集团公司政策和当地法律要求。

·         Participate in the construction of new
plant, such as document preparation, on-site supervision, etc.

·         Participate in the new equipment
qualification, especially for the PQ.

·         Assisting the Technical Engineer to
transfer the product to clinical or commercial production.

·         Participate in all PPQ related
activities, RA, protocol, training, execution, report.

·         Assisting the Technical Engineer to
prepare the RA and protocol for cleaning validation.

·         Participate in solving the process
issue during the production.

·         Ensure that all applicable Safety,
Health & Environment requirements are fulfilled to comply with corporate
group policy and local legal requirements.

Requirement任职要求

• 药学、机械类大学本科及以上学历；
• 英语四级及以上；
• 具有良好的沟通和写作能力；
• 具有较强的工作责任心和执行力。
• Bachelor degree
  or above in pharmacy and machinery。
• CET-4 or above。
• Good
  communication and writing skills。
• Strong sense of
  responsibility and execution。