Analyst I Quality Assurance & Regulatory Affairs (Analyste I Assurance Qualité et Affaires Règlementaires)
On-siteMarseille, Provence-Alpes-Côte d'Azur, France
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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