PAt Astek, we are seeking a bValidation Specialista CSV / CSA /bto collaborate with our partner in the pharmaceutical industry in an international setting /ppbr/ppb Your mission, should you choose to accept it… /b /ppbr/pulliLead computerized system validation activities in GxP environments /liliDefine and execute validation strategies aligned with CSV and CSA principles /liliProduce and review validation documentation (URS, FS, DS, IQ/OQ/PQ, risk assessments) /liliEnsure compliance with regulatory requirements (FDA, EMA, GAMP5) /liliPromote the transition from the traditional CSV approach to the CSA approach (risk-based and efficiency-driven) /liliCollaborate with quality control, IT, and business stakeholders /liliIdentify opportunities to optimize validation processes /li /ulpbr/ppb Who are you? /b /ppbr/ppWe are looking for someone with the following knowledge and experience: /ppbr/pulliMore than 5 years of experience in computer system validation (CSV) and emerging computer software assurance (CSA) practices. /liliProven experience in validation within the pharmaceutical sector (CSV required). /liliClear understanding of CSV versus CSA. /liliSolid knowledge of GxP, GAMP5, and regulations. /liliFluency in English and strong collaboration skills in international teams /li /ulpbr/ppb Who are we? /b /ppbr/ppSince 2015, Astek Iberia has been accompanying its customers in their development throughout Spain (Madrid, Barcelona, Valencia, Basque Country, Andalusia, Galicia, etc.). /ppFounded in France in 1988, Astek is a global player in engineering and technology consulting, present in five continents and 25 countries. With expertise in a wide range of industrial and service sectors, Astek is an essential partner, supporting its customers in an intelligent deployment of their products and services, and in the implementation of their digital transformation. /ppToday we are more than 8,000 employees, committed every day to promote the complementarity between digital technologies and complex systems engineering. /ppbr/ppbOur style is to have flexible schedules and highly value the well-being of our employees. /b /ppbr/ppbWhy join us? /b /ppbr/p