Karin Andersen Email & Phone Number

Copenhagen, DK

Hørsholm, Hovedstaden, Danmark

Hørsholm

Overall responsible for quality compliance in the area of Strategy, Market Access and Marketing. Securing and driving the quality mindset, identify and driving projects on further improvement. Recognised as a sparring partner and a guide for management and colleagues. Ensuring in close cooperation with relevant stakeholders outside SAM that the area is on.

Søborg

Overall responsible for the BE compliance as well as the quality in the area of Marketing and Medical Affairs. Securing and driving the quality and compliance mindset, identify and drive projects to improve it further. Recognised as a sparring partner and a guide for management and colleagues. Ensure in close cooperation with relevant stakeholders outside.

Hørsholm, Denmark

Project tasks for the area including setting up training management overviews, corporate project on introduction of an electronic work flow system for Change Management. Auditor.

Main QA tasks: Delegate QP, auditor, general quality support to the organisation, recall management, management of quality aspects of the contracted production.Main compliance activities: Implementation of a BE compliance programme from our mother company in the Nordic Organisation. Compliance responsible for Nordic organisation reporting to the Country.

Overall responsible for quality assurance activities in the company. This includes overall responsible for the QMS, ensuring correct handling of IMP and GCP and SOP training of staff. Furthermore planning, conduct and reporting of internal audits, preparing participate and follow-up on inspections from authorities and customers. Responsible for the.

Overall responsible for the companys compliance to GLP, GCP and GMP. Maintenance of the QMS for GLP, GCP and GMP. Auditing GCP and GMP. Training. The company was active in 2 phase III trials and initiating IMP production with contract manufacturers, but had to close down due to lack of financial ressources.

- QA responsible for the SVP area of International Marketing in NN (appr. 150 persons located in Copenhagen and in Zürich).- Responsible for support in all aspects of quality of NN Affiliates in Southern Europe, Eastern Europe and all states in former USSR area.- Representing interests of Affiliates in project groups and other foras in NN HQ.Participating.

- QA responsible for Scandinavia (Iceland, Norway, Finland, Denmark and Sweden)- Regulatory responsible for Iceland and Denmark- Pharmacovigilance responsible for Iceland and Denmark.

- Daily manager of the "Core Labelling Group" taking care of labelling devleopment in projects and maintenance of "neutral"/basic UK labelling for all products. - Responsible for the Change Control Committee handling the process of change control for all country specific labelling world-wide.

- Regulatory responsible for all countries in area (former USSR).- Manager with respect to professional issues of local regulatory staff (appr. 5 persons) and two employees locally in Copenhagen.- Initiating QA work in the distribution chain of the area.- Responsible for local QA issues in different projects aiming at local production.- Training of local.

M.Sc., Dentistry

Education record