Our client is integrating a new products segment into its global IT landscape for Manufacturing and ERP( SAP S/4 mainly Supply Chain and Distribution focus). We are looking for a CSV Computer Systems Validation/GXP specialist to help formulate the CSV Plan, the CSV Test Plan and preparing a CSV Validation Summary to meet regulatory and quality expectations. Meet audit readiness and support external inspections. The products are personal care consumables (to classs II medical devices) via multi sales channels incl. supermarkets.
Fluent English/excellent communication skills are essential. Experience in global complex IT systems (North America and Europe). The IT project is managed in Europe - the production site is in the USA.
Able to conduct end to end CSV assessments for new systems, changes, and integrations. Experience performing assessments across highly integrated IT environments. Strong capability to define the required approach - full or partial validation.
Deep knowledge of GXP
Experience developing and maintaining a CSV Plan, defining scope, approach, roles, and validation strategy
Ability to review system documentation (Functional Specification, Technical Specification, Configuration Specification) and determine validation scope
Ability to prepare, review, and approve a CSV Test Plan, including test scope, test design, and acceptance criteria
Ability to create and evaluate Test Reports, ensuring accurate execution evidence and clear traceability of test outcomes
Traceability management from requirements, testing, and release
Skilled in preparing the CSV Validation Summary, consolidating findings, deviations, mitigation actions, and final validation conclusions
Ability to challenge teams to ensure systems meet regulatory and quality expectations
Ability to ensure audit readiness and support external inspections
Experience with deviations, CAPA, root cause analysis, and remediation plans
Knowledge of tools supporting validation
Projects that involved meeting compliance in both the USA and Europe.
Location: Remote for EU and USA
Type: Contract
Start: asap
Duration: 6 Months 60-100%
Rate: remote rate + travel
