Computer Systems Validation - Consultant- Hybrid
Core
Consultant providing Computer Systems Validation (CSV) services to Life Sciences and Healthcare clients, ensuring compliance with FDA, EMA, and ICH regulations.
Role type
Senior IC Computer Systems Validation Consultant
Builds
Validation deliverables, policies, procedures, and test packages for computerized systems in regulated environments.
Domain
Life Sciences / Healthcare / Regulatory Compliance
Required skills
Computer Systems Validation (CSV), Regulatory Compliance (FDA 21 CFR 11, EU Annex 11, GAMP 5, ALCOA+), SDLC (Agile/Waterfall), CAPA management, Risk-based validation, Data integrity principles
Preferred skills
AI integration in systems, Experience with JIRA/Trackwise/Veeva Vault, Inspection readiness (FDA/EMA audits)
Technologies
JIRA, Trackwise, Veeva Vault, MS Office Tools
Responsibilities
Prepare and execute validation deliverables for computerised systems, Advise clients on CSV best practice and regulatory compliance, Complete validation activities to client requirements, Support clients in risk-based approach and process improvement, Provide CSV guidance for resolving documentation corrections and test defects, Monitor systems to ensure compliance with SOPs and audit requirements, Manage validation change control documentation and CAPA programmes, Apply risk-based validation principles to assess system impact, Drive inspection readiness activities including gap assessments and mock audits
Seniority
Consultant, hands-on IC