Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist

Key Responsibilities

- Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance (CSA) principles, with a focus on patient safety, product quality, and data integrity.
- Lead validation lifecycle activities for GxP-regulated systems, including:

- Requirements and specifications

- Traceability

- Testing and test execution

- Deviations and investigations

- Change control

- CAPA support

- Audit readiness activities
- 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 can be leveraged based on:

- Risk assessment

- Intended use

- Vendor qualification/assessment

- Release impact

- Quality agreements

- Support

- Infrastructure Qualification (IQ)

- Computer System Validation (CSV)

- Computer Software Assurance (CSA)
- Functional and system risk assessments
- IT quality, compliance, and governance activities in regulated Life Sciences environments
- Support both Agile and Waterfall software development lifecycle activities.
- Assess data integrity controls, including:

- Audit trails

- User access management

- ALCOA+ principles

- Data lineage

- Interfaces and integrations

- Manual processes

- Connected systems
- Support validation of AI/ML-enabled systems by evaluating:

- Intended use

- Data quality

- Explainability

- Human oversight





- Drift monitoring

- Revalidation triggers
- Apply knowledge of pharmacovigilance processes, system workflows, regulatory requirements, and supporting documentation to validation activities.
- Coordinate validation activities across multiple applications and systems while managing schedules, dependencies, deliverables, and stakeholder communications.

- Support

- IQ/OQ execution

- User story development

- Test planning

- Training material development

- Content authoring
- Provide project and operational support for eLearning and Learning Management Systems (LMS), including implementation, integration, maintenance, and sustainability activities.
- Track assigned actions, manage deadlines, and proactively escalate risks and issues.

Required Qualifications
- Experience working with GxP-regulated systems and Computer System Validation (CSV).

- Solid knowledge of

- GAMP 5

- CSA (Computer Software Assurance)

- Data Integrity
- Risk-Based Validation

- Experience preparing and managing

- Validation documentation

- Requirements Traceability Matrix (RTM)

- Test scripts and execution

- Deviations

- Change management

- Audit readiness activities





- Experience working with

- SaaS platforms
- Cloud-hosted applications

- Qualified cloud infrastructure
- Strong hands-on experience with CSV and/or CSA in Agile delivery environments.
- Experience applying a risk-based validation approach to:

- Agile releases

- Features

- User stories

- Product increments
- Experience integrating quality, compliance, and validation activities into Agile and Hybrid SDLC frameworks.

- Experience in

- IT Quality

- IT Compliance

- IT Risk Management

- Quality Oversight
- Strong stakeholder management, documentation, coordination, and delivery management skills.
- Practical knowledge of infrastructure and network components, including:

- Servers

- Virtual Machines (VMs)

- Storage systems

- Databases

- Load balancers

- Networking fundamentals
- Understanding of cloud service models, including:
- Infrastructure as a Service (IaaS)
- Platform as a Service (PaaS)
- Software as a Service (SaaS)

- Hybrid Cloud

- Managed Services

Preferred Qualifications
- Hands-on experience with:

- JIRA
- qTest

- ServiceNow

- ValGenesis
- Experience supporting eLearning Platforms or Learning Management Systems (LMS).

- Experience developing

- Training materials

- User guides
- eLearning content
- Experience within Life Sciences, Pharmaceutical, Biotechnology, or Healthcare environments.
- Familiarity with validation and compliance requirements for AI/ML-enabled systems.

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