Client: One of the leading consulting Tier 1 firm

Title: Computer System Validation(CSV)

Experience: 4 – 14 years

Location: Hyderabad, Bengaluru, Chennai, Pune

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.

Kindly share your updated resume at [email protected] along with your notice period/availability to join (Immediate to 15 days preferred).

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.
- Robust 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.

📌 Computer System Validation Consultant (Bengaluru)
🏢 Artech Infosystem Private
📍 Bengaluru