Description

Key Skills: GxP, CSV, GAMP 5, FDA 21 CFR Part 11, Software Testing, QA, Validation, Test Planning, JIRA, Requirements Analysis

Good to Have Skills: Experience in regulated industries such as Pharma, Life Sciences, Healthcare, or Medical Devices. Knowledge of EU Annex 11 compliance requirements. Experience with test management tools like ALM and Zephyr. Strong understanding of SDLC and STLC processes. Experience in defect lifecycle management and mentoring junior team members.

Roles & Responsibilities:

• Lead validation and testing activities for GxP-regulated systems and applications across multiple projects.
• Define and implement comprehensive test strategy, test plans, and validation approaches for CSV projects.
• Review and approve validation deliverables including URS, FS, DS, RTM, IQ, OQ, and PQ documents.
• Ensure compliance with regulatory standards such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and internal QA policies.
• Coordinate and manage end-to-end validation lifecycle activities for system implementations and upgrades.
• Develop and execute comprehensive test cases for functional, integration, regression, and UAT testing scenarios.
• Perform risk-based testing and ensure appropriate test coverage for critical business processes and system functionalities.
• Collaborate effectively with business users, QA teams, developers, and compliance teams throughout project lifecycle.
• Ensure complete traceability between requirements and test cases through Requirements Traceability Matrix management.
• Mentor and guide QA testers and junior validation team members in best practices and methodologies.
• Review and improve validation processes to enhance efficiency and compliance with regulatory requirements.
• Participate actively in release planning and change control processes for validated systems.

Experience Required: Strong experience in Software Testing/QA with focus on GxP and CSV environments. Hands-on experience in preparing and reviewing validation deliverables. Experience working in regulated industries

Key Skills

Education

Any Graduate