Computer System Validation( CSV)

Job description

Role & responsibilities Required Qualifications • Experience with GxP-regulated systems and computer system validation. • Working knowledge of GAMP 5, CSA, data integrity, and risk-based validation. • Experience with validation documentation, traceability, testing, deviations, change management, and audit readiness. • Experience working with SaaS, cloud-hosted applications, or qualified cloud infrastructure. • Strong experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA) in agile delivery environments. • Experience applying a risk-based validation approach to Agile releases, features, user stories, and product increments • Experience integrating quality, compliance, and validation activities into Agile and hybrid SDLC frameworks • Experience in IT quality, IT compliance, IT risk management, and quality oversight • Strong stakeholder coordination, documentation, and delivery-management skills.. • Practical knowledge of infrastructure and network components, including servers, virtual machines, storage, databases, load balancers etc. • Understanding of cloud service models, including IaaS, PaaS, SaaS, hybrid cloud, and managed services Preferred Qualifications • Hands-on experience with JIRA, Qtest, ServiceNow and ValGenesis. • Experience with eLearning or learning-management platforms. • Experience developing training materials and authoring eLearning content. Preferred candidate profile