Profil #26240

I am experienced within Quality with over 10 years of expertise in the biopharmaceutical, food, medical device, and cosmetic production industries. My professional journey has equipped me with a robust understanding of quality management systems, regulatory compliance, and industry best practices. I drive for enhancing product and procedure safety
Quality process improvements document control problem solving GMP compliance Root cause analysis CAPA Team leadership change management cross-functional collaboration  
Opdateret 27. april 2025
Min uddannelse
2012 - 2015

Cand.polyt. i Farmateknologi

Danmarks Tekniske Universitet - DTU

Uddannelsesområde: Kemi, Biotek & Materialer
Periode: februar 2012 - juni 2015
2008 - 2010

cand.scient. i Molekylær Biomedicin

Anden uddannelsesinstitution i udlandet

M.Sc. in Biomedical Sciences (120 ECTS) from University of Iceland

Final Thesis: PARP inhibition tested in a mammary epithelial cell line model (90 ECTS). Supervisor: Prof. Jórunn Erla Eyfjörð
Uddannelsesområde: Medicinal & Sundhed
Periode: juni 2008 - oktober 2010
2005 - 2010

BSc. Biologi

Anden uddannelsesinstitution i udlandet

B.Sc. in Biology (180 ECTS) from University of Iceland

Final Thesis: Identifying Neural Stem Cells using Neural-Colony Forming Assay. Supervisor: Dr. Ólafur Eysteinn Sigurjónsson, The Icelandic Blood Bank.

Certification: Laboratory Animal working certification acc. to FELASA guide. category B.
Uddannelsesområde: Naturvidenskab
Periode: august 2005 - juni 2010
Min erhvervserfaring
2023 - nu

Head of Quality

Virksomhedsnavn skjult

Primex produces chitosan from shrimp shell.
In this job:
  • I Oversee Primex‘s quality management system, the quality team and laboratory.
  • I am Chairmen of the Quality Council and HACCP group.
  • I Prepare and implemente quality assurance policies and procedures.
  • I am Responsible for communication with contract manufacturers and authorities.
  • I Review all quality agreements (customers/suppliers/contract manufactures) as well as specifications for products and processes.
    • - I am Responsible for internal and external audits, as well as staff training.
    Arbejdsområde: Produktion
    Periode: oktober 2023 - nu
    2022 - 2023

    Manager QC Bioassay

    Virksomhedsnavn skjult

    Alvotech is a biosimlar pharmaceutical production company with headquarters in Iceland.

    With the QC Bioassay team advancing to account for the increased production, I was invited to step up for Manager to lead the department through upcoming changes and complex expansion.
    Arbejdsområde: Ledelse & Planlægning
    Periode: marts 2022 - oktober 2023
    2020 - 2022

    Team Leader QC Bioassay

    Virksomhedsnavn skjult

  • Managing a team of scientist in quality testing, validation, and transfer of methods, while ensuring adherence to GxP to allow regulatory success.
  • Implementation of several site wide procedures and processes for activities such as invalid assay procedure, reference material system and OOS/OOT investigations.
  • Monitor performance of the department via agreed KPIs, ensuring the to meet the timelines to achieve facility readiness to obtain license to operate as a GMP facility.
  • Responsible for strategic and change management for the team and the department.
  • Audit/inspection responsibility (FDA, EMA, IMA).
  • Responsible for data integrity for the Bioassay group data management and a part of the Quality data integrity force.
    • - Extensive GxP experience (SOP, Deviations, Change Controls, CAPA, OOS/OOT/OOR, Training documents etc.).
    Arbejdsområde: Ledelse & Planlægning
    Periode: marts 2020 - marts 2022
    2018 - 2020

    QC Bioassay Senior Scientist

    Virksomhedsnavn skjult

  • ELISAs and cell-based potency assays: Measuring release drug product and stability samples (residual HCP and residual Protein A).
  • Cell banking, testing, and releasing cell banks for use- counting, splitting, images, testing
  • Working according to GMP. Writing GMP documents (SOP, Forms, Deviations, OOS/OOT/OOR, Training documents etc.). Reviewing documents and material.
  • Training of employers in methods, laboratory – and/or company procedures.
  • Responsible for technical transfers of methods.
    • - Audit/inspection experience (FDA, EMA, Icelandic authorities), responsible for Bioassay Lab and - - Bioassay GMP work in auditions/inspections.
    Arbejdsområde: Forskning & Udvikling
    Periode: august 2018 - marts 2020
    Mine kompetencer
    Evner
    capa management change management coaching and mentoring teams communication skills continuous improvement cross-functional collaboration decision-making internal and external auditing iso standards) operations management problem-solving process optimization quality management regulatory compliance (gmp risk management root cause analysis strategic planning team leadership
    Sprog på arbejdsniveau
    dansk engelsk islandsk
    Mine præferencer
    Jobtype
    Fuldtidsjob
    Arbejdsområde
    Forskning & Udvikling Ledelse & Planlægning Medicinal & Sundhed Naturvidenskab Produktion
    Geografi
    Nordsjælland Storkøbenhavn Udlandet (øvrige) Vestsjælland Østsjælland
    Læs mere / links
    https://www.linkedin.com/in/an...
    Kontakt mig!