Karin Andersen's Location
Copenhagen, Capital Region of Denmark, Denmark, Denmark
Karin Andersen's Contact Details
Karin Andersen work email
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Karin Andersen personal email
n/a
About Karin Andersen
Karin Andersen is a Selvstændig at K.A. Consult. She possess expertise in pharmaceutical industry, regulatory requirements, glp, regulatory affairs, gmp and 9 more skills. She is proficient in Russian, Italian, German, French and English.
Karin Andersen Work Experience Details
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SelvstændigK.A. ConsultCopenhagen, Dk
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Chief Qa ProfessionalAlk Dec 2023 - PresentHørsholm, Hovedstaden, Danmark -
Senior Quality & Inspection ManagerAlk Aug 2018 - PresentHørsholm
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Manager, Systems & InspectionsAlk Oct 2018 - Dec 2023
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Associate Global Qa Director, Strategy Access And Marketing, Corporate QualityNovo Nordisk Feb 2017 - Jul 2018 -
Senior Quality ManagerNovo Nordisk A/S, Executive Office Of Sam; Svp Area Of Strategy, Access And Marketing Jan 2016 - Feb 2017Overall 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 top of requirements. Representing the area in HQ driven projects to ensure business needs are taken into considerations for new activities in the quality area. Developing and conducting quality training for employees.
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Senior Compliance & Quality ManagerNovo Nordisk A/S, Mma Excecutive Office, Evp Area Of Marketing And Medical Affairs Jun 2013 - Jan 2016SøborgOverall 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 MMA that the area is on top of requirements. Representing the area in HQ driven projects to ensure business needs are taken into considerations for new activities in the compliance and quality area. Develop and run training for employees in compliance and quality.
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Qa AdvisorAlk Abello May 2012 - May 2013Hørsholm, DenmarkProject tasks for the area including setting up training management overviews, corporate project on introduction of an electronic work flow system for Change Management. Auditor.
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Senior Qa Officer & Compliance OfficerSandoz A/S Nov 2009 - Apr 2012Main 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 Head Nordics, including approval of DK promotional activities and general training of the organisation in BE compliance. Handling Compliance cases for the organisation. -
Quality Assurance ManagerPhaseonetrials A/S Sep 2008 - Nov 2009Overall 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 database of trial patients. Responsible for contact to the contracted pharmacy. Ensure yearly QMS reviews in cooperation with CEO. The position had direct reference to the CEO and dotted reference to the Head of the Board of Directors. The company went into bankrupcy in November 2009. -
Head Of Quality AssuranceAstion Pharma A/S Sep 2007 - Aug 2008Overall 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. -
Principal ScientistNovo Nordisk A/S Apr 2001 - Jul 2007- 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 in project groups in my area of expertise (Change Control, Non-conformities, Eletronic training documentation system, Patient registries)
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Scandinavian Head Of QualityNovo Nordisk Scandinavia Ab Apr 2000 - Mar 2001- QA responsible for Scandinavia (Iceland, Norway, Finland, Denmark and Sweden)- Regulatory responsible for Iceland and Denmark- Pharmacovigilance responsible for Iceland and Denmark.
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Specialist / Team LeaderNovo Nordisk A/S Mar 1998 - Mar 2000- 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.
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Regional Regulatory ManagerNovo Nordisk Regional Office East Jan 1993 - Feb 1998- 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 staff.- During ½year half-time employment in NN Vienna office preparing this unit for ISO certification.
Karin Andersen Skills
Pharmaceutical Industry
Regulatory Requirements
Glp
Regulatory Affairs
Gmp
Change Control
Validation
Regulatory Submissions
21 Cfr Part 11
Fda
Biotechnology
Cro
Biopharmaceuticals
Quality Control
Karin Andersen Education Details
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Københavns TandlægehøjskoleDentistry -
Kildegård Gymnasium
Frequently Asked Questions about Karin Andersen
What company does Karin Andersen work for?
Karin Andersen works for K.a. Consult
What is Karin Andersen's role at the current company?
Karin Andersen's current role is Selvstændig.
What is Karin Andersen's email address?
Karin Andersen's email address is ka****@****isk.com
What schools did Karin Andersen attend?
Karin Andersen attended Københavns Tandlægehøjskole, Kildegård Gymnasium.
What skills is Karin Andersen known for?
Karin Andersen has skills like Pharmaceutical Industry, Regulatory Requirements, Glp, Regulatory Affairs, Gmp, Change Control, Validation, Regulatory Submissions, 21 Cfr Part 11, Fda, Biotechnology, Cro.
Who are Karin Andersen's colleagues?
Karin Andersen's colleagues are Maria Christensen, Detlef Gärtner, Sara Borregaard Larsen, Anette Broend, Mads Tvede Møller, Yi Wang, Sofie Emilie Hornslet.
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