ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the worldās toughest diseases and make peopleās lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond whatās known today.
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ABOUT THE ROLE
Role Description: Amgen India is a key contributor to the companyās global digital transformation initiatives, delivering secure, compliant, and user-friendly digital solutions. As part of the Global Medical Technology ā Medical Information team, you will play a critical role in ensuring quality, compliance, and performance across Amgenās Medical Information platforms.
In this role, you will serve as a Senior Application Test Analyst, responsible for supporting the validation and quality assurance of enterprise applications through structured testing processes. You will contribute to the creation and execution of test cases, capture test evidence, and log and track defects to resolution. This role is crucial in maintaining the accuracy, compliance, and performance of systems used in regulated environments, including GxP.
You will work closely with development, quality, and validation teams to deliver trusted solutions that serve healthcare professionals and patients around the world.
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Roles & Responsibilities:
Ā· Design and develop functional and regression test cases for Salesforce-based systems, including Lightning components, custom objects, workflows, validations, and integrations.
Ā· Support User Acceptance Testing (UAT) by coordinating test activities, preparing relevant Salesforce scenarios, and assisting end users.
Ā· Configure and manage test data in Salesforce environments (standard and custom objects) aligned with test case preconditions.
Ā· Execute structured testing phases including Dry Runs, Operational Qualification (OQ), Functional Testing, and Regression Testing, ensuring all scripts align with validation requirements.
Ā· Conduct System Integration Testing (SIT) to validate end-to-end workflows and ensure seamless data flow across integrated systems.
Ā· Capture and upload test evidence, screenshots, logs, and results to HP ALM, ensuring all test steps and validations are properly documented.
Ā· Log, track, and prioritize defects in HP ALM, linking them to corresponding test cases and working with the Salesforce development team for resolution.
Ā· Perform re-tests and confirm defect closure, ensuring the integrity of fixes and absence of regression issues across Salesforce functionality.
Ā· Execute manual test scripts for Salesforce features, including access control (roles/profiles), data security, UI consistency, and business workflows.
Ā· Work closely with Salesforce developers, business analysts, and administrators to validate system behavior post-deployment and patch releases.
Ā· Validate security configurations, field-level permissions, page layouts, and record visibility to ensure compliance with Amgenās internal controls and GxP standards.
Ā· Participate in Salesforce release cycle testing, including sandbox validations, data migrations, and impact analysis of new features.
Ā· Ensure all testing activities, including test planning, execution, and defect management, are fully traceable and audit-ready in HP ALM for CSV and regulatory compliance.
Ā· Support audit and inspection readiness by maintaining structured documentation of test artifacts and validation evidence.
Ā· Actively contribute to Agile/Scrum ceremonies by sharing testing insights, risks, and quality updates during sprint planning, reviews, and retrospectives.
Ā· Continuously improve QA processes and recommend enhancements to test case reusability, ALM usage, and collaboration between cross-functional teams.
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Basic Qualifications
Masterās degree and 5 to 8 years of Computer Science, IT or related field experience OR
Bachelorās degree and 5 to 8 years of Computer Science, IT or related field experience
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Preferred Qualifications:
Ā· BS/MS in Computer Science, Information Technology, Life Sciences, or a related field
Ā· 5+ years of experience in manual testing and system validation in a regulated (GxP/CSV) environment
Ā· Strong understanding of test lifecycle documentation, including test plans, RTMs, OQ scripts, and summary reports
Ā· Familiarity with test management and defect tracking tools (e.g., JIRA, HP ALM, qTest)
Ā· Experience working in Agile/Scrum teams within healthcare or pharmaceutical domains
Ā· Experience in validating GxP-critical systems per 21 CFR Part 11, Annex 11, and data integrity standards
Ā· Exposure to or interest in automation testing tools and concepts (e.g., Selenium, CRT, UI Path etc.)
Must-Have Skills
Ā· Hands-on experience in designing, executing, and documenting manual test cases, particularly for Salesforce-based systems, including Lightning components, workflows, and custom objects.
Ā· hands-on experience in working with Salesforce backend, configuration, test data management, and Salesforce administration
Ā· hands on experience UX/UI testing across multiple devices and browsers, ensuring consistent user experience
Ā· Proficient in using HP ALM (or equivalent tools) for planning, executing test runs, capturing test evidence, and managing defect lifecycles with full traceability.
Ā· Ability to log, track, and verify defects, link them to test cases, and collaborate with development teams for resolution and re-testing within structured QA cycles.
Ā· Experience executing manual test scripts related to roles/profiles, data security, record visibility, UI consistency, and Salesforce business workflows.
Good-to-Have Skills
Ā· Experience testing within regulated healthcare or pharmaceutical domains, where compliance and data integrity are critical.
Ā· Interest or exposure to automation tools such as Selenium, CRT, UI Path or other test frameworks for potential process optimization.
Ā· Experience supporting Salesforce release testing, sandbox validation, UAT coordination, and post-deployment verifications.
Ā· Familiarity with writing and maintaining Requirements Traceability Matrices (RTMs), OQ protocols, test plans, and validation summary reports.
Ā· Active involvement in Agile ceremonies such as sprint planning and retrospectives, with the ability to share insights, raise risks, and contribute to continuous QA improvement.
Ā· Solid understanding of GxP and Computer System Validation (CSV) standards, including 21 CFR Part 11 and Annex 11, with experience maintaining audit-ready documentation and validation evidence.
Ā· Experience in Performance and Load testing
Professional Certifications:
Ā· ISTQB Foundation or Advanced Level Certification
Ā· Certified CSV/Validation Professional (optional)
Ā· SAFe Agile or Scrum Certification (preferred)
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Soft Skills:
Ā· Detail-oriented with a strong commitment to accuracy and documentation
Ā· Excellent analytical and problem-solving skills
Ā· Strong interpersonal and written/verbal communication abilities
Ā· Ability to work independently and in collaboration with cross-functional teams
Ā· Proactive, self-motivated, and adaptable in a dynamic environment
Ā· High level of accountability and ownership of assigned tasks
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