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QA Scientist Copenhagen Denmark,  


Posted on : 23 May 2017

Project Description

QA Scientist Location Region Hovedstaden City Copenhagen Department Research and Development Application deadline 06 June 2017 Description We are looking for a colleague with passion for quality assurance to join the GLP QA team within QA & Knowledge Management as a QA Scientist.The GLP QA team, which is based in Copenhagen, assures Non-Clinical Safety Research by auditing study plans, data and study reports to ensure that data and study documents for the worldwide registration of new NCEs are compliant with Good Laboratory Practice. Moreover, GLP QA team conducts screen audits and compliance audits of contract research organisations abroad.We cooperate proactively with the organisation to obtain the most efficient quality system. Besides the quality assurance work we also review regulatory documents such as non-clinical overviews and non-clinical summaries and support the organisation with technical assistance to the EDMS system and administrative assistance to project overviews.Your job and key responsibilitiesAs a QA Scientist, you will be expected to:Audit study plan, study data and study reports from our analytical laboratories or from contract research organisations.Lead audits of contract research organisations often placed in Europe or US.Be a QA contact person for a specific analytical laboratory.Be a QA focus team member in Lundbecks development project teams in which you support the team with information on regulatory requirements.The position is based in Lundbeck s headquarters in Copenhagen, Denmark. Some travel can be anticipated due to auditing of contract research organisations (5-10 days / year).We offerA challenging position in a dynamic department with dedicated colleagues.QualificationsOur preferred candidate has the following professional and personal qualifications:Life science education e.g. Master degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong interest in quality.At least 3-5 years  of experience with GLP, GCP or GMPLead auditor experiencesExperiences within analytical science will be an advantageYou must speak and write English fluently.Strong engagement, credibility and empowerment.Decisive and embrace complex tasks via constructive dialogue and in cooperation with QA colleagues and collaborators in Non-clinical Safety Research.Further informationFor further information, please contact Bj

Locations

Region Hovedstaden Copenhagen

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