Specialist IS Business Analyst
HyderabadFull-timeJunior levelPosted over a month ago
Data analytics role at Amgen in Hyderabad.
About the role
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 strong validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.
What you'll do
- 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
- 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
What you need
- SOP writing
- Internal audit
- GMP
- Salesforce