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Data Validation Specialist

vor 1 Monat


Bern, Bern, Schweiz Capgemini Vollzeit

About Capgemini Engineering Switzerland

We are a dynamic company that values excellence, diligence, responsibility, dynamism and innovation. Our diverse workplace offers opportunities for professional and personal growth.

Job Overview

  • Assess and produce CSV packages on assigned projects with accountability for the work produced.
  • Plan, coordinate, and execute computer system validation of production and QC Lab systems.
  • Prepare, review, and approve technical and GMP-related documentation.
  • Understand customer needs and define electronic records requirements.

Required Skills and Qualifications

  • Bachelor's or Master's degree in technical or natural sciences.
  • At least 4 years of experience in CSV validation.
  • 3+ years of experience in pharma or biotech companies.
  • Familiarity with FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.

Benefits

  • 30-70% remote work flexibility (40% for cross-border employees due to tax regulations).
  • Support for trainings, formation upon agreement with the manager.
  • Congenial team culture and rituals.

Salary: The estimated annual salary for this position is between CHF 80,000 and CHF 120,000 depending on location and experience.