Qualification & Validation Expert - Computerised Systems Quality
Sanrafaelvet
Val-de-Reuil, Eure, France
Onsite
Validation and qualification of computerised systems
Application of quality procedures and standards
Regulatory inspection readiness
As a Qualification & Validation Expert, you will be responsible for quality validation activities of existing and new computerised systems to ensure successful regulatory inspections and process improvements
Job Summary
As a Qualification & Validation Expert, you will be responsible for quality validation activities of existing and new computerised systems to ensure successful regulatory inspections and process improvements.
Sanofi offers a supportive and forward-looking team environment with numerous opportunities for talent development and career progression, including promotions and internal mobility.
Employees benefit from extensive health and wellness advantages, including high-quality healthcare, prevention programs, and at least 14 weeks of parental leave regardless of gender.
Matching Summary
As a Qualification & Validation Expert, you will be responsible for quality validation activities of existing and new computerised systems to ensure successful regulatory inspections and process improvements.
Skills & Requirements
Must-have
Validation and qualification of computerised systems
Application of quality procedures and standards
Regulatory inspection readiness
Quality representative for IT systems lifecycle
Management of validation documentation
Handling quality events and corrective actions
Nice-to-have
Client orientation and results focus
Innovation and proposal capacity
Ability to convince and federate
Cross-functional collaboration skills
Key Requirements
Experience in pharmaceutical industry quality or production
Knowledge of GAMP5, GMP/BPF, and 21CFR part 11
Bachelor's degree plus 5 years in scientific field