Experte/-in Qualifizierung (80 - 100%)

Roche Holding AG

Basel, Switzerland
Not specified
5-7 years practical experience in qualification
Technical gmp requirements implementation
Fda and ema regulatory compliance knowledge
Roche Holding AG is seeking a qualified expert in qualification for their Site Infrastructure Engineering Circle in Basel, Switzerland. The role involves maintaining GxP-qualified statuses of equipment and systems, ensuring compliance with internal and regulatory requirements, and engaging with internal stakeholders

Job Summary

  • The role involves creating and maintaining GxP qualified status for infrastructure, equipment, and systems within the Basel/Kaiseraugst site.
  • Candidates will lead qualification activities in medium investment projects and present findings during audits and inspections by regulatory authorities.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters to advance healthcare solutions globally.

Matching Summary

Match Score: 85

Roche Holding AG is seeking a qualified expert in qualification for their Site Infrastructure Engineering Circle in Basel, Switzerland. The role involves maintaining GxP-qualified statuses of equipment and systems, ensuring compliance with internal and regulatory requirements, and engaging with internal stakeholders.

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

  • Experience with electronic qualification systems
  • Fluency in German and English languages
  • Ability to work in agile organization
  • Strong communication and negotiation skills
  • Support for internal customers as advisor

Key Requirements

  • University degree in technical field
  • 5-7 years experience in pharmaceutical or biotech environments
  • German and English language proficiency

Work Rights

Not specified

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