Expert:in Qualifizierung (80-100%)

Roche

Basel, Switzerland
Not specified
5-7 years practical experience in qualification
Technical gmp requirements implementation
Fda and ema regulatory compliance knowledge
Roche is seeking an Expert in Qualification to join their Site Infrastructure Engineering team in Basel, Switzerland. The role involves creating and maintaining GxP qualification documentation for various systems and equipment, requiring significant experience in GMP environments along with strong communication skills

Job Summary

  • The role involves creating and maintaining GxP qualified status for critical infrastructure equipment and systems within the pharmaceutical environment.
  • Candidates will lead qualification activities, manage audits by regulatory authorities, and serve as a technical advisor on GMP matters.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent, stop, and cure diseases.

Matching Summary

Match Score: 85

Roche is seeking an Expert in Qualification to join their Site Infrastructure Engineering team in Basel, Switzerland. The role involves creating and maintaining GxP qualification documentation for various systems and equipment, requiring significant experience in GMP environments along with strong communication skills.

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
  • Fluent German and English communication skills
  • Ability to work in flat agile organization
  • Strong negotiation and interpersonal skills

Key Requirements

  • University degree in technical field
  • 5-7 years experience in pharmaceutical qualification
  • Proficiency in German and English languages

Work Rights

Not specified

Tailored Resume

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