Business Quality Representative For Manufacturing Digital Solutions
Sanofi
Budapest, Hungary
Hybrid
Gxp computerized systems compliance
Quality data integrity principles
Computer system validation (csv)
The Manufacturing & Supply Quality Digital Solutions team drives the transformation of Quality operations at Sanofi by simplifying, standardizing, and digitalizing processes across Quality Management Systems and related projects
Job Summary
The Manufacturing & Supply Quality Digital Solutions team drives the transformation of Quality operations at Sanofi by simplifying, standardizing, and digitalizing processes across Quality Management Systems and related projects.
As a Business Quality Representative, you will support validation activities, review documentation, and collaborate with cross-functional teams to maintain quality standards for digital solutions in a pharmaceutical manufacturing environment.
Sanofi offers a supportive, future-focused international work environment with comprehensive health and wellbeing benefits, structured onboarding, and a strong commitment to diversity, equity, and inclusion.
Matching Summary
The Manufacturing & Supply Quality Digital Solutions team drives the transformation of Quality operations at Sanofi by simplifying, standardizing, and digitalizing processes across Quality Management Systems and related projects.
Skills & Requirements
Must-have
GxP computerized systems compliance
Quality data integrity principles
Computer system validation (CSV)
Quality risk management
Cross-functional team collaboration
Review of URS and validation protocols
Nice-to-have
Proactive problem-solving approach
Effective written and verbal communication
Willingness to learn quality systems
Experience with ERP, MES systems
Pharmaceutical manufacturing exposure
Key Requirements
5+ years pharmaceutical quality assurance experience
Professional English proficiency
Degree in Life Sciences, Pharmacy, Engineering, Computer Science or related
Knowledge of FDA 21 CFR Part 11 and EU Annex 11
Experience with GxP regulations and computerized systems