Qa Specialist- Regulatory Affairs

GE HealthCare UK

Not specified; not specified; benefits described a...
Not specified
Gmp quality assurance experience in sterile manufacturing
Hands-on qms process execution including deviations capa
Strong understanding of gdp and data integrity expectations
The job posting is for a Systems QA Specialist in Regulatory Affairs at GE HealthCare UK, focusing on providing Quality System support in a sterile manufacturing environment. The role involves managing QMS processes, ensuring compliance, and working cross-functionally to maintain inspection readiness and effective documentation

Job Summary

  • The Systems QA Specialist provides critical Quality System support and oversight for a sterile manufacturing site operating terminal sterilisation within an aseptic filling environment.
  • This role focuses on strengthening compliant quality systems through robust documentation, change control, deviation management, and risk assessment to ensure safe product supply.
  • GE HealthCare offers a culture that fosters care, collaboration, and support with global strength and scale, providing career opportunities and flexible total rewards.

Matching Summary

Match Score: 85

The job posting is for a Systems QA Specialist in Regulatory Affairs at GE HealthCare UK, focusing on providing Quality System support in a sterile manufacturing environment. The role involves managing QMS processes, ensuring compliance, and working cross-functionally to maintain inspection readiness and effective documentation.

Salary

Not specified; Not specified; Benefits described as unlocking ambition with flexibility

Skills & Requirements

Must-have

  • GMP Quality Assurance experience in sterile manufacturing
  • Hands-on QMS process execution including deviations CAPA
  • Strong understanding of GDP and data integrity expectations

Nice-to-have

  • Experience with terminal sterilisation lifecycle activities
  • Ability to drive continuous improvement in QMS workflows
  • Cross-functional collaboration with Engineering and Validation teams

Key Requirements

  • Bachelor's degree in Science, Engineering, Pharmacy, or related discipline
  • Experience in GMP Quality Assurance within sterile/aseptic environments
  • Hands-on experience supporting QMS processes like deviations and CAPA

Work Rights

Not specified

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