Sofia Horkeby Email & Phone Number

Gothenburg, SE

Gothenburg, Vastra Gotaland County, Sweden

In my current role I am working in development projects, making regulatory assessments and ensuring regulatory compliance by performing regulatory planning activities in order to secure a successful launch. I am also supporting and submitting regulatory applications worldwide to achieve market access

Gothenburg, Sweden

As a QA Engineer R&D I supported development projects on Design Control and Product Risk Management. I reviewed technical documentation and assured compliance to external and internal requirement on Design Control. Design Reviews and identification, evaluation and mitigation of Product Risks were part of my daily work.

As a Package Development Specialist at Santa Maria I work with development of new packaging concepts as well as improvement of existing packages.The work requires an holitic view to met the needs throughout the value chain; from the manufacturing at our Suppliers of packaging material, via our production, warehouse, distribution, handling in store.

As an R&D Process Coordinator I worked with continous improvement with Lean R&D as a guiding star. I had a delegated responsibility of the Product Development Process (PDP) and was responsible for Standard Operation Procedures connected to Design Control. I educated my collegues in the PDP and in DMIC, a tool for root cause analyses.

For Medical Device the sterility of the product is crucial, so the product protection that the Packaging System Provides is of outmost importance. I worked with package development in development projects to secure the functionality of the sterile barrier in combination with the outer case. I was also responible for making sure that the development.

My work at Tetra Pak included sub project management, where I was responsible of the Technical Packaging Development. I worked closely with Machine Development, Materal Development and Customer/Consumer understanding to create a packaging specification that met the high set demands from internal and external stakeholders.

Msc, Chemical Engineering With Focus On Material Science

Master Of Science, Chemical Engineering

Activities and Societies: Ölchef i kemis Public Relations förening HÄKS. Engagerade mig i Internationella Utskottet och tog hand om kemis.