Senior Specialist Quality Assurance, CSV

Role: Senior Specialist Quality Assurance (CSV SME) responsible for ensuring GxP computerized systems compliance throughout their lifecycle, including validation, qualification, and maintenance. Primary objectives include supporting risk-based validation processes, vendor evaluations, system implementations, and change controls in alignment with regulatory standards (GAMP 5, 21 CFR Part 11, Data Integrity). Responsibilities encompass partnering with IT and business teams to define SDLC and validation requirements, reviewing validation documentation, guiding data integrity practices, and leading investigations into CSV deviations and system failures. The role also involves internal audits, maintaining inspection readiness, and supporting validation of AI/ML-enabled GxP systems and new product introductions. Requirements: 7+ years in pharma/biotech, with 5+ years in CSV validation lifecycle management; Bachelor's in life sciences; deep understanding of 21 CFR Part 11, CSV, CSA, GAMP 5, GDPR; experience with SaaS/PaaS validation and data migrations; familiarity with AI/ML systems in regulated environments; proven review of validation deliverables. HighValue: validation of GxP systems, SaaS/PaaS, AI/ML systems, Data Integrity, regulatory compliance. WorkSetup: Not specified.