ilb Consulting Services

Engineer

• Provide CSA / CSV subject matter expertise across Pharmacovigilance, Clinical, and Regulatory Affairs platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation, including URS, specifications, test plans, and test summaries, in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met before 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
• Support user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance
• Assess compliance impacts of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation
• Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation
• Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process improvements
• Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support

Explore CSA Consultant/Senior Validation Engineer at ilb Consulting Services. Review requirements and application details.

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CSA Consultant/Senior Validation Engineer