Lise Thiim

Process Engineering Specialist

Personal | Process Support | Quality Coordinator

Summary

Lise has a wide range of competences acquired through more than 20 years of experience from Pharma Industry. She has held positions as Validation Specialists, Quality Lead, Quality Coordinator, and Process Supporter in various API manufacturing processes. She has been responsible for all phases in planning and execution of qualification and validation activities, and she has been a trainer in validation principles for several years.

Previously, she worked in various facilities in the Novo Nordisk API sites in Kalundborg and in Clayton, USA.

Special Competences

Process Validation in GMP manufacturing processes: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA) requirements to Qualification and Validation.
Quality Coordinator: Follow up on quality related issues and coordination of audits and inspections.
Process Support: Implement changes, perform CAPAs and root-cause analyses. Create procedures and perform training activities.
Personal: Maintain overview, open-minded, proactive & solution oriented

Project Experience

Validation Facilitator
Facilitating qualification and validation activities in a department which runs the major equipment/system change projects in an API facility. Participation in projects as a Validation responsible person performing project planning and execution of validation activities (DER, DQ, FAT, SAT, IQ, OQ, PQ, PV)