Tecnimede Group is a 40 years Portuguese multinational company that wants to improve and preserve human life and health through the development, production and marketing of pharmaceutical products with a strong focus on quality and technological innovation. The group covers the entire life cycle of the medicinal products for human use with a strong investment in research and development.
We are looking to reinforce our team with a Senior Serialization Technician Key Responsibilities Manage the company's serialization solution (CSDB), ensuring proper functionality, data reliability, and compliance with applicable directives.Act as the single point of contact (SPoC) for regulatory bodies (e.g., EMVO, MVO-PT) and business partners (clients and CMOs).Coordinate the integration of new serialization projects, from validation to operational implementation.Support the implementation of new legal and customer requirements, translating them into internal processes and system configurations.Oversee master data management (GTINs, GLNs, Unique Identifiers) and ensure proper parameterization of traceability systems.Ensure non-conformity resolution and continuous process improvement in collaboration with Quality, Production, and IT teams.Manage daily reconciliation of serialization data throughout the logistics process (production, delivery, returns, destruction, etc.).Collaborate with internal departments (Production, Quality, IT, Supply Chain, Regulatory) to maintain and continuously improve the system.Conduct data integrity analyses and drive improvements in serialization systems and processes.Support user training, develop, and maintain applicable documentation (SOPs, work instructions, technical reports) in alignment with Good Manufacturing Practices (GMP) Required Profile Bachelor's or Master's degree in Engineering, Information Systems, Pharmacy, Management, or a relevant field.Minimum 3–5 years of experience in pharmaceutical serialization within a GMP environment.Experience with CSDB (preferred) or other serialization systems (e.g., SAP ATTP, TraceLink).Solid knowledge of applicable regulations (EU Directive 2011/62, Decree-Law No. 176/2006, etc.).Strong proficiency in SAP, Microsoft Excel, and data management tools.Ability to work independently, analytical mindset, and strong communication skills with technical and regulatory teams.Solid project management, problem-solving, and technical communication skills.Fluency in English (written and spoken) for international collaboration and interaction with authorities and partners. Valued Differentiators Experience in audits, inspections, and interactions with regulatory authorities.Participation in serialization system implementation projects and integration with partners.Knowledge of Power BI or other reporting and data analysis tools.Experience in computer system validation under GxP practices (GAMP5), including URS definition and qualification testing (IQ, OQ, PQ).Technical leadership skills and experience managing multidisciplinary projects in an international context. In accordance with the provisions of the GDPR and other legislation in force on personal data protection, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent, and limited to the purposes for which your data was collected.