Description
IT Validation Lead Senior/Computer System Validation (CSV)
Location: Walloon Brabant
Start date:
Actual End Date: + possible extension
Summary:
To support the Validation activities to Computerized Systems for each assigned project.
Essential duties & responsibilities:
* Responsible for assuring the Computerized Systems meet the requirements of the systems users;
* Creating, managing, and/or maintaining the documents required by quality systems procedures for the development and validation of the Computerized System;
* Responsible for oversight of protocol execution;
* Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures;
* Coordinate risk management of new or changed computerized Systems;
* 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,...).
Requirements:
* Minimum 5-7 years of experience in validation industry standards;
* At least 1 year as a validation lead
* Good knowledge of Supply Chain & Quality processes;
* Knowledge of Supply Chain Systems such as ERP, Warehouse Management System, Service Management System is required;
* Good communication skills, fluent in English;
* Knowledge and experience in the following areas:
o Documentation Management using document management tool
o Test Management using HP Quality Center