Quality Specialist And Qualified Person

Roche Holding AG

Sofia, Bulgaria
**
Batch certification of medicinal products
Knowledge of gmp and gdp regulations
Management of deviations and capa programs
** Roche Holding AG is seeking a Quality Specialist and Qualified Person in Sofia, Bulgaria, to ensure compliance with pharmaceutical quality standards. The role involves batch certification, quality oversight, and collaboration with various stakeholders to maintain the integrity of the Pharmaceutical Quality System. **

Job Summary

  • This role ensures life-saving medicines reach patients safely while maintaining full compliance with regulatory requirements.
  • You will certify and release commercial medicinal products for the local market, ensuring every batch meets quality standards.
  • Roche fosters a culture of personal expression where employees are valued, accepted, and respected for their unique qualities.

Matching Summary

Match Score: 75

** Roche Holding AG is seeking a Quality Specialist and Qualified Person in Sofia, Bulgaria, to ensure compliance with pharmaceutical quality standards. The role involves batch certification, quality oversight, and collaboration with various stakeholders to maintain the integrity of the Pharmaceutical Quality System. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Fluency in English language
  • Proficiency in ERP systems
  • Experience in international environments
  • Commitment to integrity and courage

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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