Description

You will lead validation and testing activities for GxP-regulated systems across multiple projects.

This role is on-site.

Responsibilities

• Define and implement test strategy, plans, and validation approaches for CSV projects.
• Review and approve validation deliverables including URS, FS, DS, RTM, IQ, OQ, and PQ.
• Develop and execute test cases for functional, integration, regression, and UAT scenarios.
• Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and EU Annex 11 standards.
• Mentor QA testers and junior validation team members on best practices.

Required Skills

• 5+ years in Software Testing/QA with focus on GxP and CSV environments.
• Hands-on experience preparing and reviewing validation deliverables.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and GxP regulations.
• Proficiency in test planning and requirements analysis.
• Experience with JIRA for test management and defect tracking.
• Understanding of SDLC and STLC processes.

Preferred 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.

Key Skills

Education

Any Graduate