CSV Specialist

Job SummaryWe 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 strategiesRequired 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 - Bachelor’s degree in Engineering, Computer Science, or a related field

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