Tecnimede Group: Improving and Preserving Human Life
About Us
As a 40-year-old Portuguese multinational company, we are committed to developing, producing, and marketing high-quality pharmaceutical products that incorporate cutting-edge technology. Our focus on research and development enables us to cover the entire lifecycle of medicinal products for human use.
Job Description
We are seeking a Senior Serialization Technician to join our team.
Key Responsibilities
* Serialization Solution Management: Ensure proper functionality, data reliability, and compliance with applicable directives for our serialization solution (CSDB).
* Regulatory and Business Partnerships: Serve as the single point of contact for regulatory bodies (e.g., EMVO, MVO-PT) and business partners (clients and CMOs).
* New Project Integration: Coordinate the integration of new serialization projects from validation to operational implementation.
* Legal and Customer Requirements: Support the implementation of new legal and customer requirements by translating them into internal processes and system configurations.
* Master Data Management: Oversee master data management (GTINs, GLNs, Unique Identifiers) and ensure proper parameterization of traceability systems.
* Non-Conformity Resolution and Process Improvement: Collaborate with Quality, Production, and IT teams to resolve non-conformities and continuously improve processes.
* Daily Reconciliation of Serialization Data: Manage daily reconciliation of serialization data throughout the logistics process.
* Collaboration with Internal Departments: Work closely with internal departments to maintain and continuously improve the system.
* Data Integrity Analysis and Improvements: Conduct data integrity analyses and drive improvements in serialization systems and processes.
* User Training and Documentation: Support user training and develop/maintain applicable documentation (SOPs, work instructions, technical reports) in alignment with Good Manufacturing Practices (GMP).
Required Profile
* Educational Background: Bachelor's or Master's degree in Engineering, Information Systems, Pharmacy, Management, or a relevant field.
* Experience: Minimum 3–5 years of experience in pharmaceutical serialization within a GMP environment.
* Technical Skills: Experience with CSDB (preferred) or other serialization systems (e.g., SAP ATTP, TraceLink), solid knowledge of applicable regulations, and proficiency in SAP, Microsoft Excel, and data management tools.
* Soft Skills: Strong analytical mindset, excellent communication skills, project management, problem-solving, and technical communication skills, with fluency in English for international collaboration.
Valued Differentiators
* Audit and Inspection Experience: Experience in audits, inspections, and interactions with regulatory authorities.
* Serialization System Implementation: Participation in serialization system implementation projects and integration with partners.
* Data Analysis Tools: Knowledge of Power BI or other reporting and data analysis tools.
* Computer System Validation: Experience in computer system validation under GxP practices (GAMP5), including URS definition and qualification testing (IQ, OQ, PQ).
* Technical Leadership: Technical leadership skills and experience managing multidisciplinary projects in an international context.