Per Rønsholt Andresen

Co-founder, specialist and senior project manager

GMP | Personal | Project management | Technology

Summary

Per has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects though his work for a variety of national and international bio-tech/life science /pharmaceutical/medical device companies both early stage (new products) and late stage (mature products) where he has been responsible for:

• Qualifying suppliers and setup up supply chains (under FDA/EU regulation), • Temperature mapping and qualifying various production rooms,
• Reporting and performing risk analysis workshops,
• Root cause investigation of assembly, inspection, and packaging lines,

• Installing and upgrading equipment in pharmaceutical production facilities,
• Substantial increase of OEE (Overall Equipment Effectiveness) for two blister

packaging lines, and
• Bringing medical device and product (Biogen’s Zinbryta®) to the market.

Special Competences

Line & project management within the life science industry (<15 employees)
Technology including extensive knowledge about heat studies, packaging lines, vision and image processing
GMP: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA) requirements to Qualification and Validation

Personal: Curious, Maintain overview for complex projects, seamless handovers, open-minded, proactive & solution oriented, adaptive to the customers requirement

Project Experience

Test plans for new high-speed packaging line
Test plan writer
Wrote test plans for new high-speed / high volume packaging line Novo Nordisk A/S, Denmark – 2021 – ?