Department: Validation COE

Company: Novo Nordisk Global Business Services (GBS)

Help safeguard the systems that keep patient safety at the heart of everything we do. If you thrive at the intersection of compliance, technology and collaboration across borders, this is your opportunity to make complex GxP IT systems work seamlessly for millions of patients worldwide.

Your new role

As an IT Validation & Compliance Specialist your day-to-day tasks will include:
- Performing Computer System Validation (CSV) / Computer Software Assurance (CSA) activities in line with Novo Nordisk's Quality Management System for GAMP 5 Category 4 & 5 GxP computerised systems, including validation of AI features in GxP SaaS systems
- Defining and executing risk-based validation strategies, acting as SME and championing critical thinking, cLean principles and faster releases
- Supporting operational and maintenance activities such as Driving change and release management, including handling change requests, supporting system releases, and Coordinating incident and problem management for assigned systems,



ensuring SLA KPIs are met and producing system-specific reports with corrective actions
- Supporting periodic reviews, internal and external audits, deviation handling and creation of system documentation, SOPs, training material and user manuals
- Managing vendor performance, negotiating Work Orders and SLA addendums, and resolving operational issues with suppliers and platform owners
- Collaborating closely with System Owners, System Managers, IT/LoB SMEs, ITQA/ITQC and project team members in Denmark to ensure alignment and continuous improvement

Your skills & qualifications

We are looking for a structured and business-oriented professional who enjoys working in an international matrix organisation, with the flexibility and team spirit to thrive in a energetic environment. To succeed in this role, you will bring:
- An MCA, MTech, BCA or similar graduate degree in a relevant field, or

📌 IT Val. (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru