Product Owner - Serialization (Full remote)
20 hours ago
Ourense
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. What will your mission be? 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. - Ensure operational stability, business continuity and regulatory compliance, including incident, change and release management, KPIs and SLAs. - Ensure compliance with GxP, Computerized System Validation, audit and regulatory inspection requirements. - Manage vendors, system integrators, CMOs and other stakeholders, collaborating with Architecture, Cybersecurity, Infrastructure and Integration teams. - Drive standardization and continuous improvement of serialization and traceability processes. - Contribute strategically to the F2D2 Separation Program, supporting the definition and evolution of the future independent serialization platform. Who are you? - You have 6 years of experience in Digital Manufacturing, Serialization, MES, Supply Chain Systems or Track & Trace solutions. - You have experience managing business-critical applications in production within regulated industries, as well as complex initiatives and external vendors. - 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 Who are we? 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. Why join us? - You will grow professionally in a company that is constantly developing and evolving. - 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. - You will enjoy days full of positive energy and a great working environment. ...And there is much more for you to discover! Shall we meet? We are looking forward to meeting you! Apply with your detailed CV, and we will contact you as soon as possible!
