Specialist I&ii, Manufacturing Support

AstraZeneca

Suzhou, China
管路器具组装
溶液配置
无菌操作
Complete production tasks such as pipeline fixture assembly, sterilization, and solution preparation as planned, and manage outsourced employees to assist production with sample delivery

Job Summary

  • Complete production tasks such as pipeline fixture assembly, sterilization, and solution preparation as planned, and manage outsourced employees to assist production with sample delivery.
  • Responsible for production department cleaning and disinfection, personnel behavior and changing room management, drafting and updating relevant SOP documents, and timely tracking and handling of identified issues.
  • Participate in risk assessment, change, and deviation activities, identify GMP compliance and operational risks in the production process, and cooperate with the production lean compliance department to implement relevant CAPA and continuously improve production efficiency and quality.

Matching Summary

Complete production tasks such as pipeline fixture assembly, sterilization, and solution preparation as planned, and manage outsourced employees to assist production with sample delivery.

Skills & Requirements

Must-have

  • 管路器具组装
  • 溶液配置
  • 无菌操作
  • GMP生产环境
  • 偏差调查
  • 变更控制
  • SOP起草

Nice-to-have

  • 商业化生产经验
  • 团队协作精神
  • 沟通能力
  • 问题解决能力
  • 精益合规

Key Requirements

  • 本科及以上学历
  • 2年以上工作经验
  • 具备丰富的GMP工作经验
  • 具备偏差调查、CAPA、变更控制等质量管理工具的实际经验
  • 具备良好的文档撰写能力
  • 具备基础英语读写能力

Work Rights

Not specified

Tailored Resume

Cover Letter