Senior Validation Analyst
Core
Ensuring systems and processes comply with regulatory standards and internal quality requirements through validation plans, protocols, and reports.
Role type
Senior Validation Analyst
Builds
Validated software, systems, and processes for healthcare and clinical research clients
Domain
Healthcare / Pharmaceutical / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation plan development, Risk assessment, Regulatory knowledge (GxP, FDA, EMA), Scientific operations, Documentation for audits, Training and guidance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and execute validation plans, protocols, and reports for software, systems, and processes; Collaborate with IT, QA, and operational teams to assess validation needs; Conduct risk assessments and impact analyses; Document validation activities and maintain accurate records; Provide training and guidance to junior analysts
Seniority
Senior, hands-on IC
