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CSA/CSV Validation Consultant

ITECSArlington, VA🇺🇸United States

Why this role stands out

This role offers a fantastic opportunity to elevate your career by leading critical validation projects within the life sciences industry, all while enjoying the freedom and flexibility of a hybrid work environment. You will thrive here if you are a detail-oriented expert in GxP systems and CSA principles who enjoys making a tangible impact on quality and compliance. Apply today to join a forward-thinking team where your specialized skills will be truly valued and continuously developed.

Quick overview

SeniorityMid Senior

Work modeHybrid

LocationArlington, VA, United States

Job description

Role - CSA/CSV Validation Consultant

Remote

Skills & Experience Required:

empower or similar HPLC software

Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain
Familiarity with QMS processes including deviation management, CAPA, and change control.
Strong command of CSA (Computer Software Assurance) principles
Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+).
Proven ability to write and manage validation deliverables including Test Strategy (Risk-based testing, CSA),\ HPLC software