Role Descriptions: Computer System ValidationPlan| execute| and maintain validation activities for GxP relevant computerized systems in accordance with regulatory and internal quality requirements Develop and review validation deliverables including Validation Plans| User Requirements| Risk Assessments| Test Protocols| Test Scripts| Traceability Matrices| and Validation Summary ReportsEnsure validation activities demonstrate that systems are fit for intended use| reliable| and operate in a controlled environmentRisk Based Approach & ComplianceApply risk based validation principles aligned with regulatory expectations (e.g.| GxP| Part 11| ISO 13485) Support audits and inspections by providing explicit| complete| and compliant validation documentationAssess impact of system changes and support re validation activities as requiredChange & Configuration ManagementEnsure validated systems remain in a compliant state through effective change control and configuration management Review system updates| patches| and enhancements to determine validation impactMaintain system inventory and validation status throughout system lifecycleCross Functional CollaborationWork closely with IT| Quality| Engineering| Vendors| and Business stakeholders to support validation activitiesParticipate in system implementation projects to embed validation from early lifecycle stagesSupport training and awareness on CSV processes and regulatory expectations________________________________________________________________________________Preferred Skills & ExperienceIn-depth understanding of Computer System Validation (CSV) and Computer Software Assurance (CSA).Understanding SDLC and its various phases/ stages.Understanding and Expertise in Risk Management (ICH Q9 and ICH Q8).Understanding of GAMP categories.Understanding of Industry Standards like ISO 13485Understanding on QMS and regulations like 21 CFR Part 820Understand

📌 Computer System Validation Engineer (Bengaluru)
🏢 Cerebra
📍 Bengaluru