Specialist (m/w/d) Qualification, Validation & Assets Befristet Für 2 Jahre

Roche

Penzberg, Germany
Not specified
Qualification and validation of equipment
Asset lifecycle management experience
Knowledge of gmp, fda, iso regulations
Roche is seeking a Specialist in Qualification, Validation & Assets for a two-year contract in Penzberg, Germany. The ideal candidate will have a background in pharmacy or biotechnology, with over three years of relevant experience in product qualification and validation within the pharmaceutical or medical device industries

Job Summary

  • This role is responsible for the efficient planning and execution of qualification and validation activities within the Diagnostics Operations Penzberg team.
  • The position serves as the first point of contact for quality compliance topics including asset management, hygiene, and document control.
  • Candidates will collaborate closely with production and QC teams to ensure adherence to global standards like GMP and FDA regulations.

Matching Summary

Match Score: 85

Roche is seeking a Specialist in Qualification, Validation & Assets for a two-year contract in Penzberg, Germany. The ideal candidate will have a background in pharmacy or biotechnology, with over three years of relevant experience in product qualification and validation within the pharmaceutical or medical device industries.

Skills & Requirements

Must-have

  • Qualification and validation of equipment
  • Asset lifecycle management experience
  • Knowledge of GMP, FDA, ISO regulations
  • First level support for operational quality
  • Training production staff on compliance

Nice-to-have

  • Hands-on mentality for challenging tasks
  • Strong problem-solving and analytical skills
  • Experience in biotech or medical device industry
  • Ability to work independently with initiative
  • Fluency in German and English communication

Key Requirements

  • Degree in Pharmacy, Biotechnology, or related field
  • Minimum 3 years experience in production and validation
  • Certifications in GxP compliance preferred
  • German and English language proficiency required

Work Rights

Not specified

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