PSGS is the world#39;s leading inspection, verification, testing and certification company. The company employs over 97 000 people and operates a network of more than 2 600 offices and laboratories around the world. /p pbr /strongSGS Life Sciences /strongis a leading contract research organization offering Clinical Research Drug Development and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product. /p pTo strengthen our Business IT team, we are currently looking for a strongBusiness IT manager – CSV /strong /pbr /pstrongemYour mission /em /strong: /p pMANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT /p ul liCreate detailed project planning and project teams. /li liEstablish and follow the budget. /li liCoordinate and follow all project tasks and make sure progresses are made. /li liTry to solve and report potential issues and problems. /li liCollaborate with regional IT for projects development and implementation. /li /ul pKEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS /p ul liPrepare / collect the URS and Functional specifications. /li liOutline Test and validation plan / protocols / test cases. /li liPerform or witness test executions. /li liWrite validation reports and procedures. /li liManage / Perform Periodic Reviews to ensure the system stays in a validated state. /li /ul pENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT /p ul liWork with the managers of the site to define the super users – and back ups /li liManage the change control requests and interface with regional IT /li /ulbr /pstrongemYour profile /em /strong: /p pQUALIFICATIONS/EDUCATION /p ul liUniversity degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience. /li liLanguages: French / English /li /ul pEXPERIENCE /p ul liVery good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations. /li liProven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP. /li /ul pSPECIFIC REQUIREMENTS AND/OR COMPETENCES /p ul liGood knowledge and big interest in IT /li liFlexibility / Good planner / Team player / Good communication and reporting skills /li /ulbr /ul liPerm contract /li liFull Time /li liAttractive salary /li liCompany car and other advantages /li /ulbr / Universities, Functional Support, Pharmaceuticals, GMP, Corporate Culture, Communication, Science, Protocols, Business, Audit, Reporting Skills, Test case, Validation, Budget, Project Management, Projects, Inspection, GLP, Coordination, Evaluation, Flexibility, Change Control, URS, Education, People Management, Test Execution, Implementation