About Tecnimede Group
Tecnimede Group is a 40-year Portuguese multinational company dedicated to improving and preserving human life and health. Our focus is on the development, production, and marketing of pharmaceutical products with an emphasis on quality and technological innovation.
Our Mission
We strive to cover the entire life cycle of medicinal products for human use, investing heavily in research and development to ensure the highest standards of quality.
Job Title: 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 and business partners.
* Coordinate the integration of new serialization projects from validation to operational implementation.
* Support the implementation of new legal and customer requirements by 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.
* Collaborate with internal departments 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 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 or other serialization systems.
* Solid knowledge of applicable regulations.
* Strong proficiency in SAP, Microsoft Excel, and data management tools.
* Ability to work independently, analytical mindset, and strong communication skills.
* Solid project management, problem-solving, and technical communication skills.
* Fluency in English 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.
* Technical leadership skills and experience managing multidisciplinary projects in an international context.
Personal Data Protection
In accordance with the provisions of the GDPR and other legislation in force on personal data protection, we guarantee that the processing of your personal data is lawful, fair, transparent, and limited to the purposes for which your data was collected.