Qa Qualification & Validation Expert (m/w/d)

Catalent

Schorndorf, Germany
Computer system validation expertise
Gmp and regulatory compliance knowledge
Data integrity program management
The role involves leading Computer System Validation activities while ensuring strict adherence to GMP and regulatory requirements

Job Summary

  • The role involves leading Computer System Validation activities while ensuring strict adherence to GMP and regulatory requirements.
  • Candidates will be responsible for managing Data Integrity programs, including gap assessments and training initiatives.
  • The position offers opportunities to represent the department during regulatory inspections and customer audits at a global market leader.

Matching Summary

The role involves leading Computer System Validation activities while ensuring strict adherence to GMP and regulatory requirements.

Skills & Requirements

Must-have

  • Computer System Validation expertise
  • GMP and regulatory compliance knowledge
  • Data Integrity program management
  • SOP creation and review skills
  • Deviation and CAPA handling experience

Nice-to-have

  • Strong analytical thinking abilities
  • High self-organization capacity
  • Experience with industrial packaging processes
  • Continuous improvement project participation
  • Fluency in German and English languages

Key Requirements

  • Degree in Natural Sciences or Engineering with Life Sciences focus
  • First relevant professional experience in Pharma or Food industry
  • Very good knowledge of German language in speech and writing

Work Rights

Not specified

Tailored Resume

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