Description
CSV Validation Engineer: Computer Systems Validation, ERP
A world renowned pharmaceutical organisation are seeking an English speaking CSV Validation Engineer to work onsite in their R&D site near Brussels, Belgium. The successful candidate will be responsible for creating, managing, and/or maintaining the documents required by their quality systems procedures for the development and validation of the Computerized Systems.He/she will control the Validation Package and ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures.
Further responsibilities include:
* Ensure design review and application acceptance including completeness of Trace Matrix (link among user requirements, functional requirements, design requirements and test plan);
* Communicate and control the adherence to validation standards by the team;
* Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures).
* Support the processes to maintain in a controlled state of validation during the entire life cycle of Computerized Systems part of the ERP systems
* Good knowledge of Supply Chain & Quality processes in the pharmaceutical industry;
* Knowledge of Supply Chain Systems such as ERP, Warehouse Management System, Service Management System;
* Good communication skills