Descripción de la oferta
At Astek, we are seeking a Validation Specialista CSV / CSA to collaborate with our partner in the pharmaceutical industry in an international setting Your mission, should you choose to accept it… Lead computerized system validation activities in GxP environments Define and execute validation strategies aligned with CSV and CSA principles Produce and review validation documentation (URS, FS, DS, IQ/OQ/PQ, risk assessments) Ensure compliance with regulatory requirements (FDA, EMA, GAMP5) Promote the transition from the traditional CSV approach to the CSA approach (risk-based and efficiency-driven) Collaborate with quality control, IT, and business stakeholders Identify opportunities to optimize validation processes Who are you? We are looking for someone with the following knowledge and experience: More than 5 years of experience in computer system validation (CSV) and emerging computer software assurance (CSA) practices. Proven experience in validation within the pharmaceutical sector (CSV required). Clear understanding of CSV versus CSA. Solid knowledge of GxP, GAMP5, and regulations. Fluency in English and strong collaboration skills in international teams Who are we? Since 2015, Astek Iberia has been accompanying its customers in their development throughout Spain (Madrid, Barcelona, Valencia, Basque Country, Andalusia, Galicia, etc.). Founded 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. Today we are more than 8,000 employees, committed every day to promote the complementarity between digital technologies and complex systems engineering. Our style is to have flexible schedules and highly value the well-being of our employees. Why join us?
