We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sciences/Pharmaceutical domain. The ideal candidate should have hands-on expertise in validating GxP regulated systems, ensuring regulatory compliance, and supporting clinical and quality applications.
Job Title: Computer System Validation (CSV) / Validation Consultant Life Sciences
Location: Remote
Duration: Long Term
Must Have Skills
8+ years of experience in Computer System Validation (CSV)
Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations
Experience in IT Compliance and validation lifecycle
Validation of IT Systems and regulated applications
Hands-on experience with Veeva Quality Docs
Experience with JIRA and HP ALM
Validation of Safety Systems
Experience with Argus Safety
Experience with Veeva Vault
Experience working on Clinical Trial Systems
Knowledge of CTMS (Clinical Trial Management System)
Preparation and review of validation documents (URS, IQ, OQ, PQ, RTM, Validation Plan, Validation Summary Report)
Strong communication and stakeholder management skills
Responsibilities
Execute end-to-end Computer System Validation activities.
Prepare and review validation documentation.
Ensure systems comply with GxP and regulatory requirements.
Coordinate with business, QA, IT, and vendors during validation.
Support audits and compliance activities.
Validate clinical, quality, and safety applications.
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