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Amgen
Senior Specialist - IT Quality
Senior Specialist IT Quality at Amgen, Hyderabad. Lead GxP system validation, CSA methodology, change controls. 10+ yrs QA experience, 5+ leadership. Competitive benefits, collaborative culture.
Direct Hire
Senior
ServiceNow Role Type:
System Administrator
ServiceNow Modules:
Change Management
ServiceNow Certifications (nice to have):
Certified System Administrator
Job description
Posted on:
September 3, 2025
Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Requirements
- Proficient with CSA (Computer Software Assurance) methodology to focus validation on high-risk areas and reduce redundant testing for GxP Systems.
- Lead the complete lifecycle of GxP system validation: risk assessment, Business requirements, configuration specifications, traceability matrix, IQ/OQ/PQ protocols, and periodic review.
- Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.).
Benefits
- Competitive benefits
- Collaborative culture
- Comprehensive Total Rewards Plans
Requirements Summary
10+ years experience in Software and Systems Quality assurance, with 5+ years of leadership experience
