Computer System Validation( CSV)

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