Christian Kubel Højmose
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About Me
Hello There!
I am a unique combination of skill, a quality pharmacist with great passion for regulatory science, knowledge and experience. My curiosity always drives me to see new ways of improving the result. In connection to my task resolution I have an exceptional understanding of IT. I am a highly ethical individual with a deep thirst for management, daily operations, and challenging projects. My quality and regulatory background allows me to see issues from several
My Resume
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Work Experience
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QA/RA Specialist
Brainreader A/S - 2022 - CurrentWorking with implementation of eQMS, MDR, MDSAP and UKCA, including ISO 13485, 14971 and 27001
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QA/RA Specialist
SSI Diagnostica A/S - 2020 - 2022Working with registration of IVDs around the world, including implementation of IVDR, and new software for label management (LMS)
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QA Analyst (Complaint Investigator)
Agilent Technologies - 2020 - 2020Project management, risk evaluation, Complaint handling and Reportability Evaluation
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QA/RA Coordinator
SP Medical - 2018 - 2020Responsible for QMS managing ISO 13485, 14001 and 45001. Provided assistance to the Injection moulding department, including management review analysis, audits and software validations
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Regulatory Affairs Associate, DK/NO/IS
Teva Denmark A/S - 2017 - 2018Life Cycle Management (LCM) for Pharmaceutical products, maintenance of software registries and approval of packaging materials
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Regulatory Project Leader
Danish Medicine Agency - 2015 - 2017Life Cycle Management (LCM) for Pharmaceutical products, maintenance of software registries and approval of packaging materials
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Education
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Master of Science in Pharmacy (Cand. Pharm),
School of Pharmaceutical Sciences, University of Copenhagen - 2012 - 2014Elective Courses: Clinical Pharmacy, Clinical Drug Trial and GCP (Good Clinical Practice), Communication and information about drugs, and Research and Scientific methods in Social and Clinical Pharmacy.
Master thesis: “Documentation of organizational effect as a result of medication management review in Brønshøj, Vanøse and Husum” -
Bachelor of science in Pharmacy (Bsc. Pharm)
Faculty of Pharmaceutical Sciences, University of Copenhagen - 2009 - 2012Bachelor project: Naproxen
My Talents
QMS/eQMS
Establishment, maintaining and implementation of QMS, eQMS and processes aligned with EN ISO 13485, 14971, 27001, 45001 or 14001
Registration
Pharmaceutical, Medical Devices or in-vitro devices registration, wither via Directive 2001/83/EC (Medical products), Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR)
Analytics
Data analysis, understand and reporting with or without connection to Management Reviews
Risk Management, Design and Development
Establishment, maintaining and handling of risk management procedures, before, during or after release of new or old products.
Software and web development
Both executive, quality and regulatory support, and direct development
Project management, support and casework
Handling project, both new and old, including customer support. Large experience in casework, include handling of NC, CAPA or Changes