Sr Associate IS Analyst
Amgen · Hyderabad · onsite · Posted 45d ago
Undisclosed1–3 yrsfulltimeSourced from
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About this role
Role Overview
The Tester is responsible for executing testing and validation activities for clinical data, analytics, and reporting systems, with a strong focus on data validation, pipeline testing, and Agile delivery to ensure high-quality and reliable releases.
Key Responsibilities
- Execute end-to-end testing (SIT, UAT, IQ, OQ, Dry Runs) including test design, execution, and defect management using VVM/Veeva Vault and ALM
- Perform data validation across ETL/ELT pipelines, including SQL-based reconciliation, source-to-target validation, and verification of datasets, reports, and dashboards
- Validate system functionality, data transformations, and integrations across GxP and Non-GxP systems based on business and regulatory requirements
- Analyze and resolve data issues through defect triaging, production data validation, and ensuring data accuracy and integrity
- Ensure completeness and correctness of testing artifacts, including test scripts, execution evidence, and defect documentation for audit/inspection readiness
- Maintain end-to-end traceability (RTM) between requirements, test cases, execution results, and defects
- Support validation lifecycle activities including impact assessment, risk-based testing approaches, and validation documentation updates
- Support execution and closure of validation activities aligned with Change Requests (ServiceNow) ensuring proper documentation and approvals
- Participate in release readiness activities including test summaries, defect reviews, and go/no-go decisions
- Collaborate with Agile teams (BA, Dev, QA, Product) to deliver sprint testing outcomes and ensure timely, high-quality releases
- Contribute to continuous improvement of testing and validation practices, including standardization and automation-aligned approaches
Required Qualifications
- 58 years of experience in testing, QA, or data validation roles
- Strong experience in test case design, execution, defect lifecycle management, and test documentation
- Experience with testing tools such as HP ALM, JIRA, and Confluence
- Familiarity with functional, integration, and data validation testing approaches
- Experience working in Agile/Scrum delivery models
- Strong analytical, debugging, and problem-solving skills
- Ability to work with cross-functional teams and deliver within sprint timelines
Must Have
- Strong SQL expertise for data validation, reconciliation, joins, aggregations, and exception analysis
- Hands-on experience testing ETL/ELT pipelines (Databricks or similar) and validating data across relational databases
- Experience working with AWS data services (S3 ingestion/storage) and SQL tools (DBeaver or similar)
- Strong understanding of source-to-target validation, data quality checks, and data defect analysis
- Experience preparing test evidence and supporting validation execution in controlled environments
Good to Have
- Knowledge of Computer System Validation (CSV)
- Understanding of Risk-Based Validation (RBV)
- Familiarity with GxP and 21 CFR Part 11
- Experience with Veeva Vault / VVM
Preferred Skills
- Experience in clinical data, analytics, or reporting systems
- Familiarity with data warehouse / data lake validation concepts
- Exposure to test automation or automation-aligned practices
- Strong documentation and communication skills
Sourced from naukri
Skills
data qualityAlmAutomationAgileCfrDefect Analysisclinical datadata servicesdata warehouseConfluenceamazon web servicesCSVAgile DeliveryAnalyticsDbeaverData LakedebuggingDatabricksCommunication SkillsData Validation
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
About
Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
Industries
BiotechnologyBiotech & Life sciences
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