ppSGS is the world’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. /ppbSGS Life Sciences /b is 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. /ppTo strengthen our Business IT team, we are currently looking for ab Business IT manager – CSV /b /ppbYour mission /b: /ppbMANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT /b /pulliCreate detailed project planning and project teams. /liliEstablish and follow the budget. /liliCoordinate and follow all project tasks and make sure progresses are made. /liliTry to solve and report potential issues and problems. /liliCollaborate with regional IT for projects development and implementation. /li /ulpbKEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS /b /pulliPrepare / collect the URS and Functional specifications. /liliOutline Test and validation plan / protocols / test cases. /liliPerform or witness test executions. /liliWrite validation reports and procedures. /liliManage / Perform Periodic Reviews to ensure the system stays in a validated state. /li /ulpbENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT /b /pulliWork with the managers of the site to define the super users – and back ups /liliManage the change control requests and interface with regional IT /li /ulh3Qualifications /h3pbYour profile /b: /ppbQUALIFICATIONS/EDUCATION /b /pulliUniversity degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience. /li /ulpbEXPERIENCE /b /pulliVery good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations. /liliProven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP. /li /ulpbSPECIFIC REQUIREMENTS AND/OR COMPETENCES /b /pulliGood knowledge and big interest in IT /liliFlexibility / Good planner / Team player / Good communication and reporting skills /li /ul /p #J-18808-Ljbffr