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Job Description Your mission : MANAGE BUSINESS IT TEAM WITHIN A GMP ENVIRONMENT People management (support, evaluation, hiring) Organization of the team and assignment of the projects/tasks to the member of the team Participation to customer audit and authorities’ inspections Define priorities in collaboration with operational managers. MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT Create detailed project planning and project teams. Establish and follow the budget. Coordinate and follow all project tasks and make sure progresses are made. Try to solve and report potential issues and problems. Collaborate with regional IT for projects development and implementation. KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS Prepare / collect the URS and Functional specifications. Outline Test and validation plan / protocols / test cases. Perform or witness test executions. Write validation reports and procedures. Manage / Perform Periodic Reviews to ensure the system stays in a validated state. ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT Work with the managers of the site to define the super users – and back ups Manage the change control requests and interface with regional IT Qualifications Your profile : QUALIFICATIONS/EDUCATION University degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience. Languages: French / English EXPERIENCE Very good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations. Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP. SPECIFIC REQUIREMENTS AND/OR COMPETENCES Good knowledge and big interest in IT Flexibility / Good planner / Team player / Good communication and reporting skills