Descripción de la oferta
At ASTEK , we are looking for a Product Owner – Serialization & Traceability to join a project within the pharmaceutical sector , in the Digital Manufacturing & Supply area, focused on the management and evolution of the Serialization & Traceability ecosystem. You will be responsible for the end-to-end management and evolution of the Serialization & Traceability ecosystem, ensuring business continuity, regulatory compliance and operational performance of GxP-regulated systems while driving strategic transformation. Define the Serialization & Traceability strategy and roadmap and manage the lifecycle of platforms such as F2D2, Track4, TraceLink and Sentry . You have 6 years of experience in Digital Manufacturing, Serialization, MES, Supply Chain Systems or Track & Trace solutions. You have strong knowledge of pharmaceutical serialization and traceability , including L1-L5 architectures and data flows . You have experience with Antares serialization solutions such as F2D2, Track4, Sentry or equivalent platforms, as well as SaaS and hybrid application landscapes. You understand serialization processes including serial number lifecycle management, aggregation, commissioning, decommissioning, shipment and regulatory reporting. You have knowledge of global serialization regulations such as EMVS, DSCSA or equivalent regulations and experience with GxP and Computerized System Validation . You understand data exchanges between serialization platforms, ERP systems, CMOs, logistics providers, affiliates and health authorities. You are familiar with APIs, file-based exchanges, integration concepts, data integrity, audit trails and compliance requirements . ️Language - English C1 Since 2015, Astek Iberia has been supporting its clients 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 across five continents and 22 countries. With expertise in a wide range of industrial and service sectors, Astek is a key partner, supporting its clients in the intelligent deployment of their products and services and in the implementation of their digital transformation. Today, we are more than 7,200 employees, committed every day to promoting the complementarity between digital technologies and complex systems engineering. You will benefit from personalized support for your professional projects, tailored as closely as possible to your ambitions. You will make a real and immediate contribution to the company's development. You will enjoy 23 days of vacation (in addition to public holidays), which you can choose when you wish.
