Core Computer System Validation( CSV)

Key Responsibilities

Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance principles, focusing effort on patient safety, product quality, and data integrity.

Lead validation lifecycle activities for GxP-regulated systems, including requirements, specifications, traceability, testing, deviations, change control, CAPA support, and audit readiness.

Apply GxP expectations, GAMP 5, and CSA principles across traditional, agile, SaaS, cloud-hosted, and modern digital platforms.

Determine when supplier documentation and testing evidence may be leveraged based on risk, intended use, vendor assessment, release impact, and quality arrangements.

Support Infrastructure Qualification, Computer System Validation (CSV), Computer Software Assurance (CSA), system and functional risk assessment, IT quality, compliance, and governance activities in regulated Life Sciences environments.

Support agile and waterfall software development lifecycle activities.

Assess data integrity controls, including audit trails, user access, ALCOA+ principles, data lineage, interfaces, manual processes, and connected systems.

Support validation of AI/ML-enabled systems by considering intended use, data quality, explainability, human oversight, drift monitoring, and revalidation triggers.

Apply knowledge of pharmacovigilance processes, system workflows, regulatory expectations, and supporting documentation to validation lifecycle activities.

Coordinate validation activities across applications and systems, drive stakeholder follow-ups, and maintain schedules, dependencies, and deliverables.

Support IQ/OQ execution, user story development, test planning, training development, and content authoring.

Provide project and operational support for eLearning platforms, including understanding their implementation, integration, maintenance, and sustainability challenges.

Track assigned actions, manage deadlines, and escalate risks or issues promptly

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 withComputer System Validation (CSV)and/orComputer Software Assurance (CSA)in agile delivery environments.

Experience applying arisk-based validation approachto Agile releases, features, user stories, and product increments

Experience integrating quality, compliance, and validation activities intoAgile and hybrid SDLC frameworks

Experience inIT 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.