QA CSV Engineer

Key Responsibilities
Quality Oversight & Compliance • Provide QA oversight for CSV activities in accordance with cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and company quality policies. • Ensure project activities adhere to data integrity principles, including ALCOA+ requirements. • Review and approve validation deliverables such as: o User Requirements Specifications (URS) o Functional Specifications o Risk assessments o IQ/OQ/PQ protocols and reports o Test deviations, incidents, and change controls Project Team Participation • Serve as the QA representative on project teams for system upgrades, replacements, and new system implementations. • Ensure project schedules account for appropriate QA activities, validation timelines, and regulatory requirements. • Identify quality and compliance risks early and ensure timely escalation to the Department Manager. Stakeholder Collaboration • Work collaboratively with IT, OT, Validation, Engineering, and User departments to ensure systems are fit for intended use and compliant throughout the lifecycle. • Act as a problem solver to help teams interpret requirements, mitigate compliance gaps, and maintain project momentum. • Provide QA input during project meetings, design reviews, FAT/SAT, and qualification activities.