CSV Validation Consultant

Hi,                                      

• 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

• ISO 13485 / Quality Management exposure
• Clinical, Quality, and Pharmacovigilance system validation
• Experience working with global pharmaceutical clients
• Knowledge of SDLC and Agile methodology

• 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.