CSV Quality Assurance Specialist

We are seeking a detail-oriented CSV Quality Assurance Specialist to support a remote system validation project starting in April. The successful candidate will ensure that our computer systems, software, and IT infrastructure meet all regulatory requirements (including 21 CFR Part 11 and GxP
) and internal quality standards. You will be responsible for overseeing the validation lifecycle, from initial risk assessment through final reporting.

• Validation Documentation: Review and approve Validation Plans, User Requirement Specifications (URS), Functional Specifications, and Traceability Matrices.
• Testing Oversight: Oversee and audit the execution of IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols.
• Compliance Review: Ensure all system-related activities comply with FDA, EMA, and other relevant global regulatory standards.
• Risk Management: Conduct and document formal Risk Assessments to determine the scope and depth of validation required.
• Defect Management: Review and sign off on deviations and non-conformances discovered during testing, ensuring appropriate CAPAs (Corrective and Preventive Actions) are in place.
• Final Reporting: Author or review the Validation Summary Report (VSR) to certify the system is "fit for purpose."