IS Professional, Regulated Data Acquisition Systems

Job description

Position : IS Professional, Regulated Data Acquisition Systems Reports To: IS Quality Manager: Primary Purpose Summary: The regulated DAQ systems specialist is responsible for implementing the lifecycle management of regulated Data Acquisition (DAQ) systems in accordance with FDA 21 CFR Part 11, GxP, and internal standards. They oversee design, implementation, and maintenance activities of DAQ systems used in quality-critical processes, ensuring validated status, audit readiness, and continuous improvement. In addition, they act as application leader for Data Security Management Systems (ex: Compliance Builder). Job Responsibilities: - Own the lifecycle of regulated DAQ systems (design, architecture, security, compliance, cost management) and data security management systems. - Provide technical expertise to reach compliance with FDA 21 CFR Part 11, GMP, and Aptar IS standards. - Review and follow Validation Master Plans (VMP) for DAQ systems in collaboration with sites QA managers and IS Validation manager. - Author and maintain design and system administration documentation in IS Quality Management System. - Oversees change requests, incident tickets, and CAPA actions for regulat...