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DanaherPosted 2 months ago

Analyst I Quality Assurance & Regulatory Affairs (Analyste I Assurance Qualité et Affaires Règlementaires)

On-siteMarseille, Provence-Alpes-Côte d'Azur, France

Full TimeLarge

Job Summary

Qualification Engineer (Analyst I) responsible for Qualification/Validation activities for the site, including qualification of production and laboratory equipment, writing protocols and performing acceptance tests at supplier and customer sites (FAT/SAT), directing IQ, OQ and PQ procedures, drafting Validation Plans and Validation Reports, and managing associated non-conformities. Requires English and French fluency, and adherence to GMP and GAMP 5 rules. Demonstrates analytical and synthesis skills, diligence and teamwork; experience in qualification/validation within pharmaceutical/biotech/chemical sectors is preferred. Hybrid work arrangement available at the Marseille, France location.

Required Qualifications

  • Academic degree(s) with focus in qualification/ validation or related field
  • First experience in qualification/validation in pharmaceutical, biotech, chemical or similar industries
  • Fluency in English and French

Desired Qualifications

  • Academic degree in qualification/validation or related field
  • Experience in qualification/validation in pharmaceutical/biotech/chemical industries
  • Fluency in English and French
  • Good analytical and synthesis skills; diligence and team spirit
  • Knowledge of GMP and GAMP 5

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