Job Summary
As a Test Lead specializing in Functional Testing for Embedded Software, you will play a critical role in ensuring the quality and performance of software applications. You will be responsible for planning, deploying, and managing the entire testing effort for projects, ensuring compliance with client and internal quality standards. Your expertise will drive the enhancement of testing processes, promote best practices, and guide the QA team in delivering high-quality software solutions.
Testing Analyst (or Quality Assurance Analyst)
1. Test Planning & Design
Test Script Authoring: Create detailed User Acceptance Testing (UAT) and Performance Qualification (PQ) scripts that simulate real-world deviation scenarios (e.g., logging a major deviation, performing a root cause analysis, and escalating to CAPA).
Traceability Mapping: Ensure every business requirement in the User Requirements Specification (URS) is mapped to at least one test case in the Traceability Matrix.
Data Set Preparation: Define and create "mock data" (e.g., fake batch numbers, material codes) to be used during testing in the Vault Sandbox.
2. Execution & Defect Management
Functional Testing: Execute scripts to verify that Object Lifecycles, security permissions, and Entry Criteria (e.g., "Field X must be filled before moving to QA Review") work exactly as designed.
Integration Testing: Specifically for SAP-to-Veeva projects, verify that data flows correctly between systems (e.g., confirming a batch hold triggered in Veeva successfully updates the status in SAP).
Defect Tracking: Document and categorize system "bugs" or configuration gaps using tools like JIRA, then re-test once the Config Specialist provides a fix.
3. Compliance & Validation
CSV Documentation: Maintain strict documentation standards to satisfy 21 CFR Part 11, ensuring all test evidence (screenshots/logs) is captured and signed.
Regression Testing: After Veeva’s tri-annual system releases, perform "impact-based" testing to ensure new platform features haven't broken existing deviation workflows.
UAT Coordination: Facilitate testing sessions with Business SMEs, guiding them through the Vault UI and documenting their feedback.
4. Critical Deliverables
Test Plan & Summary Reports: Formal documents summarizing what was tested and the final pass/fail results.
Validated Traceability Matrix: The final proof that all regulatory and business requirements were met.
Signed Test Scripts: The primary evidence used during internal audits or FDA/EMA inspections
Key Responsibilities
2. Develop And Continuously Enhance Automated Tests Utilizing Frameworks Such As Testng And Junit As New System Features Are Introduced, While Also Creating Detailed Work Plans And Monitoring The Work Schedule To Ensure Timely Delivery Of Testing Outcomes In Alignment With Defined Quality Standards.
3. Create A Reusable And Scalable Test Automation Framework, Develop Comprehensive Test Strategies And Plans, Maintain Test Data In Compliance With Project Requirements, And Generate Status Reports To Mitigate Risks And Facilitate Project Escalations.
4. Mentor And Guide Qa Engineers In Leveraging The Testing Framework Effectively, Enhancing Their Technical Skills, And Boosting Overall Team Productivity.
Skill Requirements
2. Strong Understanding Of Test Automation Frameworks, Specifically Selenium And Testng
3. Solid Experience In Developing And Maintaining Test Strategies And Test Plans
4. Excellent Knowledge Of Scripting Languages Relevant To Test Automation, Such As Python
5. Familiarity With Performance Testing Tools And Methodologies
6. Ability To Analyze And Interpret Functional Specifications And Design Documents