Business Quality Representative For Manufacturing Digital Solutions

Sanofi

Budapest, Hungary
Hybrid
Gxp computerized systems compliance
Data integrity principles knowledge
Computer system validation activities
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, Quality Control, Supply Chain, Manufacturing, and Analytics-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, Quality Control, Supply Chain, Manufacturing, and Analytics-related projects.
  • As a Business Quality Representative, you will support validation activities, review documentation, address compliance risks, 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 flexible home office policies, comprehensive health and wellbeing benefits, 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, Quality Control, Supply Chain, Manufacturing, and Analytics-related projects.

Skills & Requirements

Must-have

  • GxP computerized systems compliance
  • Data integrity principles knowledge
  • Computer system validation activities
  • Quality risk management principles
  • Review of business process documentation
  • Hybrid working environment

Nice-to-have

  • Effective communication skills
  • Cross-functional team collaboration
  • Proactive problem-solving approach
  • Willingness to learn quality systems
  • Exposure to pharmaceutical manufacturing
  • Familiarity with ERP and MES systems

Key Requirements

  • 5+ years pharmaceutical quality assurance experience
  • Knowledge of FDA 21 CFR Part 11 and EU Annex 11
  • Degree in Life Sciences, Pharmacy, Engineering, Computer Science or related
  • Professional English proficiency
  • Experience with GxP computerized systems
  • Understanding of electronic records and signatures

Work Rights

Not specified

Tailored Resume

Cover Letter