(sr.) Specialist, Qs & Compliance, Biologics

Roche UK

Aseptic filling experience required
Data integrity alcoa+ compliance
Cgmp manufacturing operations support
The role involves supporting the development and oversight of robust quality systems including inspection readiness programs

Job Summary

  • The role involves supporting the development and oversight of robust quality systems including inspection readiness programs.
  • Candidates must have at least a degree in pharmaceutical sciences or related disciplines with minimum 2 years of experience in quality assurance.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases.

Matching Summary

The role involves supporting the development and oversight of robust quality systems including inspection readiness programs.

Skills & Requirements

Must-have

  • Aseptic Filling experience required
  • Data Integrity ALCOA+ compliance
  • cGMP manufacturing operations support
  • FDA/EU cGMP knowledge
  • Risk-based QA operational decisions

Nice-to-have

  • Project management skills preferred
  • Auditor training certification advantageous
  • New DP facility project experience expected
  • International regulatory network exposure
  • Continuous improvement technology implementation

Key Requirements

  • Degree in pharmaceutical sciences or life sciences
  • Minimum 2 years pharmaceutical/biotech QA experience
  • Fluent English oral and written communication skills
  • Technical writing experience required

Work Rights

Not specified

Tailored Resume

Cover Letter