Job Description

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 [Confidential Information] 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.
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.