Qualification & Validation Specialist
Core
Quality oversight of system and process validation lifecycle activities to ensure compliance with regulatory requirements and Sanofi quality standards.
Role type
Specialist in pharmaceutical qualification and validation
Builds
Qualified and validated facilities, utilities, equipment, computerized systems, manufacturing processes, and decontamination methods
Domain
Pharmaceutical manufacturing (sterile/aseptic)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, regulatory compliance (FDA/EMA), documentation (protocols, reports, traceability matrices), deviation management, change control, quality risk management (FMEA, HACCP, FTA), technology transfer support
Preferred skills
Biologics/sterile manufacturing experience, Health Authority inspection exposure, data integrity principles (ALCOA+), electronic document management systems (Kneat, Veeva)
Technologies
Kneat, Veeva
Responsibilities
Provide quality oversight of qualification and validation tasks, prepare and review validation documentation, manage deviations and non-conformances, evaluate change controls, support regulatory audits and inspections, collaborate with cross-functional teams, identify process improvement opportunities
Seniority
Mid-level specialist (5-7 years experience)
