Role Overview

Responsible for Computer System Validation activities within a pharmaceutical manufacturing environment.

Responsible for the development and execution of key validation and quality documentation including Qualification Plans, Test Plans, Requirements Traceability Matrices (RTMs), and Validation Summary Reports, ensuring full compliance with GMP, GAMP5, and regulatory standards.

Worked closely with Automation, IT, Quality, and third-party vendors to support delivery of digital manufacturing systems and ensure alignment with project validation strategies and quality requirements.

Represented the CSV function at project, automation, and IT meetings while supporting overall project execution and compliance objectives.