CSV Specialist

Job Summary

We are seeking an experienced Senior Computer System Validation (CSV) / IT QA Specialist to lead validation and quality assurance activities for enterprise GxP computerized systems within a regulated pharmaceutical environment.

The role requires hands-on expertise across system lifecycle validation, IT quality activities, inspection readiness, and regulatory compliance , with the ability to work independently and guide cross-functional teams.

Key Responsibilities

• Lead and perform risk-based validation of enterprise computerized systems (GAMP 5 aligned), including ERP, LIMS, MES, QMS, and regulated cloud applications
• Own and execute CSV lifecycle activities (validation planning, risk assessments, IQ/OQ/PQ, UAT oversight, RTM, summary reports)
• Perform and oversee IT Quality Assurance activities , including SOP development, deviation management, change control, CAPA, and periodic reviews
• Ensure data integrity and Part 11 compliance across validated systems
• Support system implementations, upgrades, migrations, and decommissioning activities from a validation and quality perspective
• Actively support regulatory inspections and audits (FDA, EMA, MHRA), including authoring responses and participating in inspector walkthroughs
• Collaborate closely with IT, QA, Compliance, Automation, and Business teams to ensure alignment between system functionality and regulatory requirements
• Review and approve validation documentation and evidence generated by internal teams or vendors
• Drive continuous improvement of CSV/IT QA frameworks , templates, and validation strategies

Required Skills & Experience

• 10+ years of hands-on experience in Computer System Validation (CSV) within regulated pharmaceutical or life sciences organizations
• Strong experience validating enterprise-level systems (ERP, QMS, LIMS, MES, PLM, CTMS, safety or regulatory systems)
• Proven exposure to and participation in regulatory inspections and audits related to CSV and IT systems
• Demonstrated experience in IT QA activities , including SOP management, deviations, CAPA, change control, risk management
• In-depth knowledge of GAMP 5 , 21 CFR Part 11 , EU Annex 11 , GxP , and data integrity guidelines
• Strong understanding of SDLC and Agile methodologies in regulated environments
• Excellent documentation, analytical, and problem-solving skills
• Strong stakeholder communication and cross-functional collaboration abilities
• Bachelors degree in Engineering, Computer Science, or a related field