Experte/-in Qualifizierung (80 - 100%)

Roche

Basel, Switzerland
Not specified (assumed to be office-based given the nature of the role in basel)
5-7 years practical experience in qualification
Technical gmp requirements implementation
Fda and ema regulatory compliance knowledge
Roche is seeking an experienced Qualifizierung Expert to join their Site Infrastructure Engineering team in Basel, Switzerland. The role involves ensuring compliance with GxP standards, managing qualification documentation, and supporting interdepartmental collaboration in a dynamic environment

Job Summary

  • The role involves creating and maintaining GxP qualified status for critical infrastructure, equipment, and systems within the Basel/Kaiseraugst site.
  • Candidates will act as a trusted advisor on technical GMP matters while leading qualification activities in medium-sized investment projects.
  • Roche fosters a culture where every voice matters, encouraging personal expression and genuine connections to advance healthcare globally.

Matching Summary

Match Score: 85

Roche is seeking an experienced Qualifizierung Expert to join their Site Infrastructure Engineering team in Basel, Switzerland. The role involves ensuring compliance with GxP standards, managing qualification documentation, and supporting interdepartmental collaboration in a dynamic environment.

Skills & Requirements

Must-have

  • 5-7 years practical experience in qualification
  • Technical GMP requirements implementation
  • FDA and EMA regulatory compliance knowledge
  • Creation of qualification documentation
  • Management of external staff

Nice-to-have

  • Agile organization adaptability
  • Strong communication and negotiation skills
  • Ability to simplify complex technical topics
  • Fluent German and English proficiency
  • First-level support for electronic systems

Key Requirements

  • University degree in technical field
  • 5-7 years experience in pharmaceutical/biotech qualification
  • German and English language fluency

Work Rights

Not specified

Tailored Resume

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