Senior QA Test Engineer

Company Overview

(Company overview details are not provided.)

Job Summary

The Senior QA Test Engineer will play a crucial role in the end-to-end testing of Interactive Response Technology (IRT) systems for clinical trials in the Lifesciences and Pharma domain. This position is essential for ensuring that study protocols and requirements are met, contributing to the overall success of clinical research projects.

Responsibilities

• Participate in the end-to-end testing of IRT systems (IVRS/IWRS) for clinical trials.
• Analyze and understand study protocols, randomization schemes, and drug supply management.
• Design and execute test cases and scripts for:
  • Subject enrollment/randomization
  • Kit assignment and inventory management
  • Depot allocation and shipment tracking
  • Visit scheduling and study calendar validations
• Review and validate IRT study configuration and data flows.
• Collaborate with Clinical Operations, Data Management, and IRT vendors to ensure study requirements are met.
• Perform User Acceptance Testing (UAT), functional, integration, and regression testing across IRT modules.
• Document defects and work with vendors/developers to track resolution.
• Ensure compliance with Good Practice (GxP), 21 CFR Part 11, and validation standards.
• Maintain traceability between requirements, test cases, and results.

Qualifications

• Bachelor’s degree in a relevant field (e.g., Computer Science, Life Sciences).
• 8 to 10 years of experience in Quality Assurance, specifically in testing IRT systems.
• Strong understanding of clinical trial processes and IRT systems.
• Experience in writing and executing test cases.
• Familiarity with regulatory compliance (GxP, 21 CFR Part 11).
• Excellent analytical and problem-solving skills.
• Strong communication and collaboration abilities.

Preferred Skills

• Experience with automated testing tools.
• Knowledge of software development lifecycle (SDLC) methodologies.
• Familiarity with specific IRT vendor systems.

Experience

• Minimum of 8 years of experience in Quality Assurance, with a focus on clinical trials and IRT systems.

Environment

• Work Mode: Hybrid (3 days in-office, 2 days remote) at Chennai Office.

Growth Opportunities

(Details on growth opportunities are not provided.)

Benefits

(Information about benefits is not provided.)

Role: Senior QA Test Engineer
Openings: 2
Location: Chennai
Salary: Not specified
Type: Full-time
Start Date: Immediately
Deadline: 2025-07-17
Min Experience: 8 years