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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,
📌 Product Owner (Madrid)
🏢 Astek
📍 Madrid