Merete Yde

Merete Yde Email and Phone Number

QMS/Quality specialist currently working @IVFtech @ IVFtech ApS
zealand, denmark
Merete Yde's Location
Copenhagen Metropolitan Area, Denmark
Merete Yde's Contact Details

Merete Yde work email

Merete Yde personal email

About Merete Yde

Quality professional with extensive experience within general quality, GMP and QMS.I have broad experience with both device and pharma legislation, but in recent years I've worked mostly within pharma, and less with medical devices.In my position as GMP supporter in LEO I performed a wide variety of quality tasks related to external manufacturing and CMOs, including handling change controls, deviations, SOP writing, and general GMP support. I also had the "unofficial" title of local IT supporter, which I acquired quite fast.I enjoy working with processes and optimization, and I am one of the very few people that actually enjoys writing SOPs, drawing process overviews, and decision trees. While I was valued in my senior QA position for my pragmatism and open mindset, I find myself contributing more, when in a LoB function, where I have more direct influence on cases and processes.I am currently working in a new position with IVFtech, where I am utilizing my skills with working with processes, IT and QMS, as well as my past experience with ISO standards and the medical device field.

Merete Yde's Current Company Details
IVFtech ApS

Ivftech Aps

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QMS/Quality specialist currently working @IVFtech
zealand, denmark
Website:
ivftech.dk
Employees:
17
Merete Yde Work Experience Details
  • Ivftech Aps
    Qms Specialist
    Ivftech Aps Jun 2022 - Present
    Nordsjælland
  • Leo Pharma
    Gmp Supporter Within Cmos And External Manufacturing
    Leo Pharma May 2020 - Jul 2021
    Ballerup, Hovedstaden, Danmark
    As GMP supporter in Biologics & External Manufacturing in LEO Pharma, I performed a number of different quality and QMS related tasks, such as;-Deviations, incl CAPAs, for both internal and external deviations-Change controls related to external manufacturing and CMOs-SOP authoring; including optimizing processes, making decision trees, process diagrams etc.
  • At Home
    Maternity Leave
    At Home Jan 2019 - Jan 2020
  • Novo Nordisk
    Qms Partner
    Novo Nordisk May 2017 - Aug 2019
    Bagsværd, Region Hovedstaden, Danmark
    QMS Partner in API Process Excellence Management, CMC API Development, R&D. My primary responsibility is project management of cross-functional QMS/Quality improvement projects, but I am also working closely together with the training and cLEAN counterparts in my new department, as well as the local QMS coordinators. Other responsibilities and tasks include;-working with process group responsibles (PGRs) in planning, executing, and maintaining quality and compliance within processes,-QMR coordinator,-audit coordination,-etc.
  • Novo Nordisk
    Senior Qa Professional
    Novo Nordisk Mar 2014 - Apr 2017
    Denmark
    Various QA tasks for Regulatory Affairs at Novo HQ, such as;Non-conformity handlingChange handlingSOP reviews and approvalsApproval of secondary packaging material Approval of documents for sec.pac developmentCAPA SMEAnd more...
  • Alcon Laboratories, Inc.
    Senior Vigilance Officer & Lvr
    Alcon Laboratories, Inc. May 2013 - Feb 2014
    Ørestad
    Responsible for all vigilance and pharmacovigilance activities in all Nordic countries, for all of Alcons products, incl:- Handling of adverse events, side effects, and other complaints- Reporting to the authorities- PSUR/PBRER submissions- Maintaining all related procedures- Training in vigilance activities- Etc
  • Alcon Laboratories, Inc.
    Vigilance Officer
    Alcon Laboratories, Inc. Jun 2012 - Apr 2013
    Rødovre
    Pharmocovigilance/Vigilance (adverse events etc)ComplaintsPSUR submittalsTeaching vigilance proceduresMaintaining and updating vigilance procedures
  • National Board Of Health
    Scientific Officer
    National Board Of Health Mar 2012 - May 2012
    Vigilance casesMonitor notified bodiesRegistration of manufacturers and devices (EUDAMED)Free sales certificatesEtc.
  • Danish Medicines Agency
    Akademisk Sagsbehandler / Scientific Officer
    Danish Medicines Agency May 2008 - Feb 2012
    Academic in product safety within medical devices
  • Statens Serum Institut
    Akademisk Medarbejder
    Statens Serum Institut Mar 2008 - May 2008
    Academic research position within genetics

Merete Yde Skills

Iso 9001 Lead Auditor Medical Devices Regulatory Affairs Lifesciences Quality System Molecular Biology Pharmacovigilance Vigilance Regulatory Submissions Quality Assurance Biotechnology Gmp Life Sciences Pharmaceutical Industry Sop Ich Gcp Capa

Merete Yde Education Details

Frequently Asked Questions about Merete Yde

What company does Merete Yde work for?

Merete Yde works for Ivftech Aps

What is Merete Yde's role at the current company?

Merete Yde's current role is QMS/Quality specialist currently working @IVFtech.

What is Merete Yde's email address?

Merete Yde's email address is my****@****isk.com

What schools did Merete Yde attend?

Merete Yde attended Københavns Universitet, Haslev Gymnasium.

What skills is Merete Yde known for?

Merete Yde has skills like Iso 9001 Lead Auditor, Medical Devices, Regulatory Affairs, Lifesciences, Quality System, Molecular Biology, Pharmacovigilance, Vigilance, Regulatory Submissions, Quality Assurance, Biotechnology, Gmp.

Who are Merete Yde's colleagues?

Merete Yde's colleagues are Marcus Gram, Natalie Lebel Kessler, Leif Nielsen, Kamilla Bjerg Boserup, Kjeld Nielsen, Marie-Louise Heise, Karl Jensen.

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