Quality CSV Engineer

Updated: March 18, 2024 05:39 AM GMT

Full-time Job in Essen, Flanders

Capgemini Holding Inc

Rijkevorsel

Your role
• You will give quality assurance oversight on (IQOQ / PQ…) protocols and reports
• You will help define and support the Validation Approach
• You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR)
• You will review CSV specific SOP'S and Templates
• You will perform risk assessments
• You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments, …)
• You will make sure that production practice are aligned with validation conclusion
• You will communicate to management about issues in the validation process
• You will attend project meetings
• You will provide QA oversight and approve deviation
• You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
• You will define validation strategies through the change control process
• You will write and implement validation... More Detail