Career Category
Information Systems
Job Description
Position Summary
Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through robust validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.
Key Responsibilities
- Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms.
- Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards.
- Author & ownership of validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports (VSRs), and Requirements Traceability Matrices (RTMs).
- Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance.




- Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities.
- Complete ownership of validation strategy, testing scope and end-to-end system validation.
- Lead and mentor Validation Engineers, establishing best practices and driving a quality-first culture.
- Partner with Product, Business, Quality, Regulatory, and Technology teams to support compliant and timely delivery of business initiatives.
- Drive continuous improvement initiatives to reduce validation cycle time while maintaining compliance and quality standards.

Basic Qualifications
- Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
- 8+ years of experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments.
- 3

📌 Specialist IS Business Analyst (Hyderabad)
🏢 AMGEN
📍 Hyderabad