The CSV Specialist performs the periodic review of validated systems documentation, to grant systems continue to operate in a validated state, considering device life cycle and applicable norms evolution.
Executes Decommissioning process, acting as document owner for Decommissioning Check List (DCL).
Works with Customer Technology Lifecycle Excellence, IT, and cross functional departments in development and implementation of an efficient Computerized Systems Validation Program for automated equipment, processes, and information management systems for the Laboratory and Manufacturing Operations.
Contribute with Customer QA and Technical Unit in harmonizing and implementing specifications. Contribute in change management and deviation tracking processes, including leading or contributing to CAPA. May contribute to developing procedures and/or protocols.