Computer Systems Validation - Consultant
Core
Consultant providing Computer Systems Validation (CSV) and validation project support for clients in regulated industries.
Role type
Consultant, Computer Systems Validation (CSV)
Builds
Validation documentation, test plans, and compliance evidence for client systems.
Domain
Life Sciences / Pharma / Regulated IT
Deliverable
client delivery
Required skills
CSV methodology, GxP computerized system applications, LIMS, Trackwise, Veeva Vault, Bug tracking tools, EudraLex Volume 4, FDA 21 CFR 11, GAMP, SDLC, Agile, Waterfall, Quality management systems
Preferred skills
CSV experience, regulated industry experience
Technologies
JIRA, GxP applications, LIMS, Trackwise, Veeva Vault, MS Office
Responsibilities
Reviewing CSV deliverables and advising on best practices, completing validation activities to client requirements, supporting risk-based approaches and process improvements, providing guidance on validation documentation corrections and test defects, monitoring systems for compliance with SOPs and audit standards
Seniority
Mid-level Consultant