Join a dynamic team as an experienced Computer System Validation (CSV) Consultant within the Life Sciences and Healthcare (LSHC) sector. This role involves planning, executing, and maintaining validation activities for GxP-regulated computerized systems, ensuring adherence to stringent regulatory requirements.

Leverage your expertise in GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 to drive compliance and innovation. This is an opportunity to contribute to a leading enterprise technology group that powers functional excellence and fosters long-term growth.

Key responsibilities include leading quality assurance and computerized system validation processes in regulated LSHC environments, with a minimum of 5 years of experience. You will act as a Validation Subject Matter Expert, supporting the development of business requirements, technical designs, and test strategies.

Define and execute end-to-end validation for IT projects and system upgrades, ensuring agility and speed in delivery. Create and review critical validation deliverables such as GxP Assessments, Validation Plans, URS, FRS, DS, Configuration Specifications, IQ, OQ, and PQ test plans. Experience in data migration, cloud validation, supplier assessments, and AL/ML validation is also expected.

Manage deviation handling, root cause analysis, and CAPA implementation. Handle change requests during the operational phase and conduct requirement and IT risk assessments. Support supplier assessments and provide guidance on IT system validation. You will also be involved in periodic reviews of IT systems to maintain validated status and assist in internal audits and inspections.

We seek a Computer System Validation Professional with at least 5 years of hands-on experience in validated systems like ERP, MRP, QMS, or LIMS, supporting global business operations. A strong understanding of regulatory requirements including GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 is essential.

Excellent communication and interpersonal skills are vital for collaborating with various organizational levels and external parties. The ideal candidate demonstrates self-confidence, the ability to deal with ambiguity, and a flexible approach to working under pressure. Strong written and oral English communication skills are mandatory.