Klaus Pedersen

Senior Consultant

GMP | Personal | Project management | Technology

Summary

Klaus has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects. He is an experienced author of most document deliverables within the finished product disciplines: Assembly, Packaging and Plastic injection moulding, and is also well experienced in design-for‐manufacture of components for plastic injection moulding.

Klaus has been responsible for managing, defining and implementing a medical production with ISO Class 8 clean room environment, included facility changes and identification of necessary organization, workflows, standard operation procedures and work instructions.

Previously, he worked 9 years at NNE where Klaus executed more than 15 projects as project manager and senior engineer. The vast majority of the evaluated projects received maximum satisfaction-grade from the customers.

Special Competences

Project management within the life science industry (<15 employees).
Technology, including solid experience in performing process risk assessment (pFMEA) and secure incorporated link to R&D component/product risk assessment (cFMECA).
GMP: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA) requirements to Qualification and Validation.
Personal: Maintain overview, proactive, open-minded & solution oriented.

Project Experience

New low volume assembly line – Medical Device Production
Project lead in performing process risk assessment (pFMEA) for a low volume assembly line, assembling a medical device.