Description

You will act as a validation representative throughout the software development life cycle to ensure systems meet business requirements and regulatory standards.

Responsibilities

• Prepare and execute validation plans, test cases, and validation summary reports.
• Review and approve change controls for validated systems in accordance with SOPs.
• Create and manage test data within testing environments to verify software functionality.
• Participate in project meetings to identify user requirements and assist in preparing system documentation.
• Analyze software defects, assess causes of test failures, and provide feedback on timeline or resource constraints.

Required Skills

• 2+ years of relevant experience in validation or software testing.
• Solid understanding of the Software Development Life Cycle (SDLC).
• Working knowledge of GCPs, applicable SOPs/WPDs, and process maps.
• Experience reviewing functional design, system design, and test plans.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project).
• Strong troubleshooting skills to analyze software defects and test failures.
• Understanding of clinical trials operational processes and terminology.
• Ability to coordinate project activities within multi-disciplinary teams.

Key Skills

Education

Any Graduate