IT Quality Specialist
AmgenHyderabad, Telangana, India
Posted October 28, 2025
Full Time
About the Company
Amgen is a biotechnology company that develops treatments for serious diseases, fostering an inclusive environment of diverse, ethical, committed and highly accomplished people.
Job Description
Join Amgen's mission to serve patients by working as an IT Quality Specialist in Hyderabad, India. In this role, you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. As a quality specialist, you will review validation/qualification packages of computerized systems for completeness and accuracy, serve as the QA contact for deviations, and participate in regulatory inspections.
Requirements
- Master's / Bachelor's degree with a minimum of 10-14 years experience in Software and Systems Quality assurance
- Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
- Proven experience in the validation of computerized systems (GxP)
- Strong decision-making abilities with the capacity to drive tasks to completion
- Leadership skills with experience leading projects, teams, or tasks
- Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise, Documentation Management Systems, LIMS, SAP and Maximo
Benefits
- Competitive Total Rewards Plans
- Comprehensive benefits
- Collaborative culture
- Opportunities for professional and personal growth and well-being