Summary

I have a wide range of competences acquired through more than 20 years of experience from Pharma and Machine manufacturing projects though my work for Novo Nordisk A/S, SVM Automatik A/S, InnoScan A/S and Stevanato Group A/S as Process- and Quality specialist, and Manager. I have been responsible for the quote to cash process and quality related to Process-, Assembly-, Pack- and Inspection- machines to medico and pharma customers.

• Secure audit readiness of QMS from national and international pharma customers.
• Customer QA contact and secure alignment of GAMP5 validation strategy.
• Move product design according to GAMP5 category 5 to category 4
• Machine design NPI fulfilment of Stage Gate Quality- and Projectmodel.
• Define processes, templates and IT-tools managing Machine design and validation.
• Move 4 company´s into one setup after acquisition.
• Root cause analyses of component variation used in high volume assembly lines.
• OEE improvements of high-volume assembly lines.
• NC and CR management on device production.
• Drive design qualification process to device assembly machine.
• Define risk-based project model for project initiation at multivendor packaging lines.

Special Competences

Change management and internal project management.  Facilitate Strategy process and scope and implement projects. Managing the big picture and scope projects according to stake holders.

Risk Based Approach to Machine Validation according to GAMP5. Define standard for Quality and Activity Plan, Function Specification, FMEA, URS management, Design Specification, Design Qualification, FAT, SAT, IQ and OQ.

Secure that documents supported the quality of the intended use.   

Personal: I am committed to identifying and implementing solutions that require an overview and focus on purpose, goals and deliverables. I enjoy teamwork and facilitate a team trough process towards unknown solutions.