Senior Specialist/associate Manager, Manufacturing Support

AstraZeneca

Suzhou, China
Not specified
管路器具组装、灭菌、溶液配置
部门内清洁外包服务人员管理
生产部门清洁消毒管理
AstraZeneca is seeking a Senior Specialist/Associate Manager for Manufacturing Support in Suzhou, China, responsible for overseeing production tasks, managing personnel, and ensuring compliance with GMP regulations. The ideal candidate should have a background in cell biology or molecular biology, with over five years of relevant experience in a GMP production environment

Job Summary

  • Responsible for completing production tasks such as pipeline fixture assembly, sterilization, and solution preparation as planned.
  • Responsible for managing outsourced cleaning service personnel within the department, including recruitment, training, KPI assessment, and work arrangements.
  • Participate in risk assessment, change, and deviation activities to 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

Match Score: 75

AstraZeneca is seeking a Senior Specialist/Associate Manager for Manufacturing Support in Suzhou, China, responsible for overseeing production tasks, managing personnel, and ensuring compliance with GMP regulations. The ideal candidate should have a background in cell biology or molecular biology, with over five years of relevant experience in a GMP production environment.

Skills & Requirements

Must-have

  • 管路器具组装、灭菌、溶液配置
  • 部门内清洁外包服务人员管理
  • 生产部门清洁消毒管理
  • 生产外包清洗服务公司对接
  • 废弃物灭活和处置
  • 生产内部非GMP物料管理
  • 生产部门储存间管理

Nice-to-have

  • 精益合规部配合
  • 风险评估、变更、偏差活动参与
  • 团队协作精神
  • 沟通能力
  • 问题解决能力

Key Requirements

  • Bachelor's degree or above in Cell Biology, Molecular Biology, or related fields
  • 5+ years of experience in solution preparation, aseptic operation, and related GMP production environments
  • Extensive GMP work experience, commercial production experience preferred
  • Practical experience with quality management tools such as deviation investigation, CAPA, and change control
  • Good document writing skills, able to independently draft SOPs, batch records, etc.
  • Basic English reading and writing skills, able to understand relevant technical documents

Work Rights

Not specified

Tailored Resume

Cover Letter