Quality Specialist And Qualified Person

Roche

Bulgaria
Batch certification of medicinal products
Management of deviations and capa programs
Conducting gxp audits of third parties
This role is pivotal for ensuring life-saving medicines reach patients safely while maintaining full compliance with regulatory requirements

Job Summary

  • This role is pivotal for ensuring life-saving medicines reach patients safely while maintaining full compliance with regulatory requirements.
  • The successful candidate will certify and release commercial medicinal products, ensuring every batch meets strict quality and safety standards.
  • Roche fosters a culture of personal expression and open dialogue where employees are valued for their unique qualities.

Matching Summary

This role is pivotal for ensuring life-saving medicines reach patients safely while maintaining full compliance with regulatory requirements.

Skills & Requirements

Must-have

  • Batch certification of medicinal products
  • Management of deviations and CAPA programs
  • Conducting GxP audits of third parties

Nice-to-have

  • Fluency in English language
  • Proficiency in ERP computerized systems
  • Experience in multifunctional international environments

Key Requirements

  • Master's Degree in Life Sciences
  • Qualified Person certification under Bulgarian Law
  • Minimum 2 years pharmaceutical QA/QC experience

Work Rights

Must meet legal requirements for Qualified Person under Bulgarian Law

Tailored Resume

Cover Letter