AMGEN Capability Center Portugal
healthcare
SeniorAssociateInformationSystemsAnalyst
“Senior Associate Information Systems Analyst at AMGEN Capability Center Portugal. Skills: software testing, GxP computerized systems, Risk-Based Validation (RBV). support testing and validation activities for Clinical study Planning & startup product team‑owned computerized systems, with a focus on GxP‑regulated environments.. execute manual & automated testing”
What You'll Achieve.
ensure systems meet regulatory, quality, and business requirements.; support audit and inspection readiness.; accelerate scientific breakthroughs and helps patients worldwide.
Industry & Context.
creative problem-solver
What They're Looking For.
Must Have
Bachelor's degree in Computer Science, Information Systems, Engineering, or a related discipline OR equivalent combination of education and experience., 1–3 years of experience in software testing, or quality‑related roles., Basic understanding of software development lifecycle (SDLC) and testing fundamentals., Experience working in Agile or hybrid Agile environments.
Nice to Have
Experience testing GxP‑regulated computerized systems (e. g. , clinical, quality, regulatory, life sciences platforms)., Familiarity with Risk‑Based Validation (RBV) and Computer Software Assurance (CSA) concepts., Exposure to validation artifacts such as: Test plans and test scripts, Validation summaries, Traceability documentation, Experience using testing or defect tracking tools (e. g. , JIRA, VVM, ALM)., attention to detail with a focus on documentation quality and compliance., Effective verbal and written communication skills with the ability to collaborate across teams.
What You'll Do.
support testing and validation activities for Clinical study Planning & startup product team‑owned computerized systems
with a focus on GxP‑regulated environments.
execute manual & automated testing
support Risk‑Based Validation (RBV) activities
collaborate with IS Analysts
and Quality partners to ensure systems meet regulatory
and business requirements.
Execute manual & automated functional
and regression testing for GxP computerized systems.
Support Risk‑Based Validation (RBV) by executing test scenarios aligned to system risk and criticality.
and maintain test cases
and validation evidence in accordance with Amgen SOPs.
and support resolution of defects using standard tools (e. g.
Veeva Validation Management(VVM)
Participate in User Acceptance Testing (UAT) with business and quality stakeholders.
Maintain compliant testing documentation to support audit and inspection readiness.
Collaborate with IS Analysts
and quality partners to support Agile delivery and continuous improvement.
How You'll Work.
Team & Collaboration
collaborate with IS Analysts, Product Owners, Developers, and Quality partners; Participate in User Acceptance Testing (UAT) with business and quality stakeholders.; Collaborate with IS Analysts, developers, product owners, and quality partners to support Agile delivery and continuous improvement.; Effective verbal and written communication skills with the ability to collaborate across teams.
Communication Scope
Effective verbal and written communication skills
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