Role : Tester / Validation Analyst ADX (Veeva eQMS)

Job Summary :

We are looking for a skilled Tester/Validation Analyst with hands-on experience in Veeva eQMS, specifically within the ADX (Audit, Deviation, Exception) module. The ideal candidate should have strong expertise in validation testing, test script creation, execution, and defect management while ensuring compliance with GxP and quality standards. The role involves participating in validation activities, executing formal test cycles, coordinating approvals, and supporting quality management system implementations within regulated environments.

Key Responsibilities :

Validation & Testing :

- Prepare comprehensive test scripts, test scenarios, and validation documentation.

- Conduct dry runs and review test cases to ensure coverage and compliance.

- Execute formal testing cycles including Functional Testing, System Integration Testing (SIT), and User Acceptance Testing (UAT).

- Document test results, observations, deviations, and defects accurately.

Veeva eQMS ADX Testing :

- Validate Audit, Deviation, and Exception workflows within Veeva eQMS.

- Ensure system configurations align with business and compliance requirements.

- Verify workflow routing, approvals, notifications, and process controls.

- Support implementation, enhancement, and validation activities related to ADX modules.

Test Management & Compliance :

- Manage testing activities using tools such as qTest, HP ALM, or equivalent test management platforms.

- Route test scripts and execution documents for review and approval.

- Maintain validation deliverables in accordance with regulatory and organizational standards.

- Support audit readiness and compliance documentation requirements.

Defect & Issue Management :

- Log, track, and retest defects identified during testing cycles.

- Collaborate with business users, developers, and functional teams to resolve issues.

- Perform regression testing following defect fixes and system updates.

Documentation & Reporting :

- Prepare validation plans, test scripts, traceability matrices, execution reports, and summary reports.

- Ensure accurate documentation and maintenance of validation records.

- Provide regular testing status updates to project stakeholders.

Required Skills & Experience :

- 3+ years of experience in Software Testing, Validation, or Quality Systems Testing.

- Hands-on experience with Veeva eQMS, preferably ADX (Audit, Deviation, Exception) modules.

- Strong expertise in :

1. Test Script Writing

2. Dry Run Execution

3. Formal Test Execution

4. Validation Documentation

5. Defect Tracking

- Experience using qTest, HP ALM, or similar test management tools.

- Knowledge of SDLC, STLC, and validation methodologies.

- Understanding of GxP, CSV (Computer System Validation), and regulated industry requirements.

- Experience in workflow testing, approvals, and routing validations.

Preferred Qualifications :

- Experience in Pharmaceutical, Life Sciences, Biotechnology, or Healthcare domains.

- Exposure to Veeva Vault applications and Quality Management Systems.

- Knowledge of regulatory compliance standards such as FDA 21 CFR Part 11 and GAMP 5.

- Experience supporting validation audits and compliance reviews.

Key Competencies :

- Analytical Thinking

- Attention to Detail

- Documentation Excellence

- Quality & Compliance Focus

- Stakeholder Collaboration

- Problem Solving

- Communication Skills

Education :

- Bachelor's degree in Computer Science, Information Technology, Life Sciences, Pharmacy, Biotechnology, or a related field.

- Relevant certifications in Software Testing, Validation, or Quality Systems will be an added advantage.