Spécialiste Validation
Core
Ensuring qualification and maintenance of validated status for equipment, processes, and systems at a pharmaceutical manufacturing site.
Role type
Validation Specialist (Quality)
Builds
Pharmaceutical manufacturing operations compliant with cGMP
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validated equipment and processes)
Required skills
Validation protocols (IQ/OQ/PQ/FAT/SAT), Risk assessment, Regulatory compliance (cGMP), Technical writing, Change impact evaluation, Continuous Process Verification (CPV), Audit support
Preferred skills
Multi-project management, Cross-functional collaboration, Trend analysis
Technologies
Microsoft Office
Responsibilities
Participate in writing and updating the Validation Master Plan (VMP); Write, execute, and review qualification protocols; Determine critical parameters and perform risk assessments; Qualify equipment, systems, and processes; Write qualification reports and track deviations; Evaluate change impacts and coordinate revalidation; Maintain Continuous Process Verification (CPV) programs; Support regulatory audits and inspections; Train equipment users on validation requirements
Seniority
Mid-level, hands-on IC
