QA Engineer

Navikenz India; Delhi, Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Navikenz India seeks a detail-oriented Validation Test Engineer to plan, execute, and document validation activities for software applications and systems in a regulated environment. You will ensure products meet business, regulatory, and quality requirements through thorough validation testing.

The role involves creating and executing validation plans, tests, and reports, reviewing requirements, tracking defects, and ensuring compliance with industry standards such as CSV, FDA 21 CFR Part 11,

Qualifications

• Strong understanding of Software Testing Life Cycle (STLC) and Software Development Life Cycle (SDLC).
• Experience in manual testing and validation methodologies.
• Knowledge of defect management tools such as Jira, Azure DevOps, or ALM.
• Experience creating and maintaining validation documentation.
• Understanding of test management and reporting tools.
• Strong analytical and problem-solving skills.

Responsibilities

• Develop and execute validation test plans, test cases, and test scripts.
• Perform SVT, UAT, and Regression Testing.
• Validate software applications against functional & regulatory requirements.
• Review BRDs, FS, and design documents.
• Identify, document, and track defects through to resolution.
• Prepare validation deliverables like Validation Plans, Protocols, Reports, and Traceability Matrices.
• Collaborate with BAs, Developers, QA, and stakeholders.
• Ensure compliance with industry standards and regulatory requirements (e.g., GxP, FDA 21 CFR Part 11, ISO).
• Participate in risk assessments and change control activities.

Skills

STLC/SDLC

Manual testing

Defect management tools

Validation documentation

Test management & reporting

Analytical & problem solving

Automation testing exposure

GAMP 5

Agile/Scrum

Education

Bachelor's degree in Computer Science/Engineering/Life Sciences

ISTQB certification

CSV knowledge (advantage)

Tools

Jira

Azure DevOps

ALM

Job description

Role Overview

We are seeking a detail-oriented Validation Test Engineer to plan, execute, and document validation activities for software applications and systems. The candidate will be responsible for ensuring that products meet business, regulatory, and quality requirements through comprehensive validation testing.

Key Responsibilities

• Develop and execute validation test plans, test cases, and test scripts.
• Perform System Validation Testing (SVT), User Acceptance Testing (UAT), and Regression Testing.
• Validate software applications against functional and regulatory requirements.
• Review business requirement documents, functional specifications, and design documents.
• Identify, document, and track defects through to resolution.
• Prepare validation deliverables such as Validation Plans, Test Protocols, Test Reports, and Traceability Matrices.
• Collaborate with Business Analysts, Developers, QA teams, and stakeholders.
• Ensure compliance with industry standards and regulatory requirements (e.g., GxP, FDA 21 CFR Part 11, ISO standards, where applicable).
• Participate in risk assessments and change control activities.

Required Skills

• Strong understanding of Software Testing Life Cycle (STLC) and Software Development Life Cycle (SDLC).
• Experience in manual testing and validation methodologies.
• Knowledge of defect management tools such as Jira, Azure DevOps, or ALM.
• Experience creating and maintaining validation documentation.
• Understanding of test management and reporting tools.
• Strong analytical and problem-solving skills.

Preferred Qualifications

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• Experience in regulated industries such as Pharmaceuticals, Healthcare, Medical Devices, or BFSI is preferred.
• Knowledge of CSV (Computer System Validation) is an advantage.
• ISTQB or relevant testing certifications are preferred.

Good to Have

• Automation testing exposure.
• Experience with GAMP 5 guidelines.
• Knowledge of Agile/Scrum methodologies.