Sr Associate IS Analyst

Amgen Technology; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Amgen Technology presents a Tester role focused on end-to-end testing of clinical data, analytics, and reporting systems. Responsibilities include data validation across ETL/ELT pipelines, SQL-based reconciliation, and regression testing within Agile teams to ensure data integrity and compliant releases.

The position emphasizes GxP/non-GxP system validation, defect management, and creating traceable validation artifacts for audits. Strong SQL, Databricks, and Veeva Vault experience are preferred.

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

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

Skills

Test design

Defect lifecycle

Test documentation

Agile/Scrum

SQL data validation

ETL/ELT testing

Databricks

AWS data services

DBeaver

Veeva Vault/VVM

GxP knowledge

Tools

HP ALM

JIRA

Confluence

Veeva Vault

Job description

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