Job title : , Computer System Validation (CSV)

Location : Hyderabad / Bangalore / Chennai /Pune

Experience :4 to 14 years

Notice period : Immediate joiner

Role & responsibilities

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 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
- Robust 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.

📌 Computer System Validation (CSV) (Bengaluru)
🏢 cirruslabs
📍 Bengaluru