GMP Computerized Systems Administration of GxP lab system software, including installation, backup, archival of data and general data management
GMP Computerized Systems Validation – support with the implementation- and validation of brand new computerized systems. Including writing and review of validation protocols and reports.
Second level ‘back-end’ support in day-to-day operation of software/systems and able to identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/or corrective actions
Maintain and understanding of new technology and their application to the department.
Collaboration with the end users within the department to enable their efficient use of the laboratory system
Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure
Consult and advise computer systems projects on the correct application of internal and external regulations
Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans.
Ensure that the internal regulations are in line with up to date regulatory requirements.
Supporting the change management process for new software or software updates: creating design specification, feedback on software setup on the Lonza OT environment etc.
Familiarity with Cell and Gene Therapies cGMPs, GAMP and basic validation practices (IQ/OQ/PQ)
