The Quality Technical Services team provides quality oversight of system and process validation lifecycle activities, ensuring compliance with Sanofi quality standards and regulatory requirements
Job Summary
The Quality Technical Services team provides quality oversight of system and process validation lifecycle activities, ensuring compliance with Sanofi quality standards and regulatory requirements.
As a Qualification & Validation Specialist, you will provide quality oversight of qualification and validation tasks, prepare and review documentation, manage deviations and change controls, and ensure regulatory compliance.
At Sanofi, you will be at the heart of ensuring that our manufacturing processes meet the highest standards — directly contributing to the safety and efficacy of medicines that reach patients worldwide.
Matching Summary
The Quality Technical Services team provides quality oversight of system and process validation lifecycle activities, ensuring compliance with Sanofi quality standards and regulatory requirements.
Skills & Requirements
Must-have
Quality oversight of validation activities
Prepare and review validation documentation
Deviation management and change control
Regulatory compliance (FDA, EMA)
Cross-functional collaboration
Nice-to-have
Continuous improvement mindset
Risk-based and science-based validation
Familiarity with paperless validation tools
Key Requirements
Bachelor's degree or higher in Science, Engineering, Pharmacy
Minimum 5-7 years of experience
Experience with FUE, computerized systems, manufacturing processes validation
Experience supporting regulatory inspections and audits