Join a leading team as a Senior Consultant specializing in Computer System Validation (CSV) within the Life Sciences and Healthcare (LSHC) sector. This role is pivotal in ensuring the integrity and compliance of computerized systems in regulated environments.

You will be instrumental in planning, executing, and maintaining all validation activities, ensuring adherence to critical regulatory standards such as GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11. Leverage your deep expertise to drive functional excellence and innovation.

Take ownership of the end-to-end validation lifecycle for IT projects and system upgrades. This includes developing comprehensive validation strategies, defining test plans, and executing qualification activities (IQ, OQ, PQ).

Key responsibilities involve creating and reviewing essential validation documentation, performing risk assessments, handling deviations and change requests, and supporting supplier assessments. You will also contribute to periodic reviews of IT systems to maintain their validated state and assist in audits and inspections.

This opportunity requires a seasoned professional with a minimum of 8 years of experience in quality assurance and computerized system validation within the LSHC industry. A strong understanding of regulatory compliance (GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11) is essential.

Demonstrated experience with enterprise-level applications like ERP, MRP, QMS, and LIMS is crucial. The role demands excellent communication, interpersonal, and collaboration skills to effectively engage with stakeholders across various organizational levels. Experience with data migration, cloud validation, AI/ML, and supplier assessments is highly desirable.