System Validation Consultant
Consultant Specialists, Inc. (CSI)
CSV Quality Specialist (On‑Site – San Diego, CA) Join a collaborative QA team at a clinical‑stage biopharmaceutical company developing next‑generation cell and gene therapies. In this on‑site contract role, you’ll lead and enhance the Computer System Validation (CSV) program, ensuring compliance across laboratories, manufacturing, and quality systems. What You’ll Do Serve as the site CSV Quality SME, providing QA oversight for computerized systems. Author, review, and approve validation documents (URS, RA, IQ/OQ/PQ, VSR, etc.). Guide project teams on validation, data integrity, and security controls. Support audits, inspection readiness, and compliance remediation. Conduct risk assessments, periodic reviews, and legacy system evaluations. Ensure systems meet FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP requirements. What You Bring Bachelors in Life Sciences and strong CSV/Quality Compliance experience. Deep knowledge of 21 CFR Part 11, GAMP 5, EU Annex 11, and GxP. Strong IT/technical background with experience in GMP systems. Proficiency with QMS tools (Change Control, Deviations, CAPA, EDMS, LMS). Excellent communication, collaboration, and project management skills. Advanced Excel/PowerPoint/Word skills and strong data integrity expertise. #J-18808-Ljbffr
Vacancy posted 21 hours ago
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