Computer System Validation Consultant

Artech Infosystem Private Limited; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Artech Infosystem Private Limited in Bengaluru seeks a seasoned CSV specialist to lead validation for a Tier-1 client. The role spans GxP-regulated systems, CSA/CSV, and risk-based validation across SaaS and cloud-hosted environments.

You will own validation lifecycle activities, ensure audit readiness, and apply governance across agile and hybrid SDLCs. C2H engagement and quick join are expected.

Qualifications

• Experience with GxP-regulated systems and CSV.
• 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 with SaaS, cloud-hosted applications, or qualified cloud infrastructure.
• Strong CSV/CSA in agile delivery environments.
• Risk-based validation applied to Agile releases, features, user stories, and product increments.
• Integrating quality, compliance, and validation in Agile/hybrid SDLC.
• IT quality, IT compliance, IT risk management and governance.
• Strong stakeholder coordination, documentation, and delivery-management.
• Knowledge of servers, VMs, storage, databases, load balancers; cloud models.

Responsibilities

• Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and CSA.
• 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 across traditional, agile, SaaS, cloud-hosted, and digital platforms.
• Determine when supplier documentation and testing evidence may be leveraged based on risk and vendor assessment.
• Support Infrastructure Qualification, CSV, CSA, risk assessment, IT quality, compliance, and governance in regulated Life Sciences environments.
• Support both agile and waterfall software development lifecycle activities.

Skills

GxP-regulated systems

GAMP 5

CSA

Data integrity

Risk-based validation

Validation documentation

Traceability

Testing

Deviations management

Change control

Audit readiness

SaaS/cloud-hosted apps

Cloud infrastructure

Agile delivery

IT quality/compliance

Stakeholder coordination

Delivery management

Infrastructure components

Cloud service models (IaaS/PaaS/SaaS)

Job description

Client: One of the leading consulting Tier 1 firm

Title: Computer System Validation(CSV)

Experience: 4 – 14 years

Note: This is a Contract-to-Hire (C2H) opportunity. Please apply only if you are comfortable with a C2H engagement model and can join within 10-15 days of selection.

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

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.