QA Computer System Validation (CSV)

Job Title: QA Computer System Validation (CSV)Location: California (Hybrid – 3 days onsite)Duration: 6 MonthsOverview:We are seeking a QA Computer System Validation (CSV) Contractor with experience validating clinical GxP systems in the biotech or pharmaceutical industry. The ideal candidate will support validation activities, ensure regulatory compliance, and maintain quality standards for clinical applications throughout the system lifecycle.Required Qualifications:Experience in QA Computer System Validation (CSV)Clinical Systems Validation experienceHands-on experience with Veeva eTMFExperience with Medidata RaveKnowledge of Clinical Data RepositoriesStrong understanding of GxP Compliance and EU Annex 11Experience with Risk-Based Validation and Data Integrity (ALCOA+)Experience supporting Audit & Inspection ReadinessAbility to develop and review Requirements & Functional SpecificationsExperience creating and executing Test Protocols & Validation ReportsExperience with SOP Development, CAPA, and Change ControlStrong Quality Assurance and Regulatory Compliance knowledgeUnderstanding of SDLCExperience within the Biotech or Pharmaceutical industryKey Responsibilities:Execute computer system validation activities for clinical GxP systems.Prepare and review validation documentation, including protocols and reports.Ensure compliance with GxP, EU Annex 11, and data integrity requirements.Support risk assessments, change controls, CAPA, and SOP development.Collaborate with cross-functional teams to maintain validated clinical applications.Support internal audits and regulatory inspections while ensuring inspection readiness.