QA validation Engineer

Updated: May 08, 2024 11:40 PM GMT

Capgemini Holding Inc

Rijkevorsel

Your role
• You will give quality assurance oversight on (IQ/OQ /PQ /PV…) 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 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 documentation (Validation Plan, Validation... More Detail