0079V6400 CSA Consultant/Senior Validation Engineer 2

0079V6400 CSA Consultant/Senior Validation Engineer 2 Please contact Amanda Mazza, are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. Key Responsibilities Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices Oversee validation readiness and ensure prerequisites are met prior to formal testing Support change control, configuration management, and release activities Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance Provide guidance on CSA-based, risk-driven validation approaches Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory compliance. Support periodic revi