QMS Professional, Novo Nordisk A/S, Soeborg, Denmark
Sabine Kornerup received her M.Sc. degree as a Pharmacist in 1999 from the University of Copenhagen, Faculty of Pharmaceutical Sciences in Denmark and has worked with quality for the past 17 years.
She began her career at the pharmaceutical company Leo Pharma within Regulatory Affairs. She changed to the Quality Assurance department and worked as a delegated Qualified Person also responsible for receiving and answering the customer complaints to the company.
Mrs. Kornerup started working in Novo Nordisk in 2000 in the Quality Assurance department as a delegated Qualified Person, releasing finished products from the packaging production. Part of the job was also to Quality Assurance approve nonconformities, change requests, Standard Operation Procedures and validation documentation of the packaging lines and cooling rooms.
Mrs. Kornerup then worked as Quality Assurance for Regulatory Affairs being part of a team Quality Assurance approving nonconformities, change requests, Standard Operating Procedures for the regulatory processes and participated in several projects and internal audits as Quality Assurance responsible. She has also served as System Manager for an IT system handling nonconformities in the clinical organisation and passed the ITIL Foundation Examination. Mrs. Kornerup was also quality advice responsible for IT systems in Research and Development globally, including audit and inspection support.
For a period of time in the career Mrs. Kornerup worked as a Senior Good Clinical Practice Advisor handling clinical trial Standard Operating Procedure deviations globally and reviewed clinical trial Standard Operating Procedures globally as Good Clinical Practice Expert.
Mrs. Kornerup has been working with quality initiatives within Novo Nordisk, including:
Project Manager for the implementation of an IT system for the handling of clinical nonconformities globally including input to the IT system, change management and process change. As part of the Project Manager role the governance of clinical nonconformities was supported and implemented globally.
Currently she is working as CAPA Subject Matter Expert training the organisation, establishing and implementing the CAPA process including conduction of CAPA Forum meetings at different management levels in the device part of clinical organisation.
Mrs. Kornerup is responsible for creating a ga
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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.
The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”
An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013