Computer System Assurance Consultant

A company is looking for a Computer System Assurance (CSA) Consultant / Senior Validation Engineer.

Key Responsibilities :

Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms

Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective

Develop and review validation deliverables including Validation Plans, Risk Assessments, and Validation Summary Reports

Required Qualifications :

5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, or Regulatory Affairs

Strong understanding of CSA principles, CSV, and SDLC processes

Experience authoring and / or reviewing validation documentation

Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations

Ability to work independently in a fast-paced, matrixed environment