Sr Solution Architect,D&T, Validation & Testing

About the role

In this role, you will be responsible for overseeing computer system validation activities across a range of cross-functional programs at West Pharma. You will also lead the team in project management, ensuring the successful and timely delivery of projects

What you'll do

• Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA)
• Perform system impact assessments and risk assessments to define appropriate validation scope and strategy
• Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and…
• Ensure compliance with Data Integrity (ALCOA+) principles, including audit trails, access management, and electronic records controls
• Support deviation management, change control assessments, and periodic review activities for validated systems

What you need

• 5–8 yrs of experience
• SAP
• ISO 9001
• GMP
• Internal audit
• B.Tech or B.E. or B.Sc or BCA