Merete Yde Email and Phone Number
Merete Yde work email
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Merete Yde personal email
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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.
Ivftech Aps
View- Website:
- ivftech.dk
- Employees:
- 17
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Qms SpecialistIvftech Aps Jun 2022 - PresentNordsjælland -
Gmp Supporter Within Cmos And External ManufacturingLeo Pharma May 2020 - Jul 2021Ballerup, Hovedstaden, DanmarkAs 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. -
Maternity LeaveAt Home Jan 2019 - Jan 2020
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Qms PartnerNovo Nordisk May 2017 - Aug 2019Bagsværd, Region Hovedstaden, DanmarkQMS 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. -
Senior Qa ProfessionalNovo Nordisk Mar 2014 - Apr 2017DenmarkVarious 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... -
Senior Vigilance Officer & LvrAlcon Laboratories, Inc. May 2013 - Feb 2014ØrestadResponsible 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 -
Vigilance OfficerAlcon Laboratories, Inc. Jun 2012 - Apr 2013RødovrePharmocovigilance/Vigilance (adverse events etc)ComplaintsPSUR submittalsTeaching vigilance proceduresMaintaining and updating vigilance procedures -
Scientific OfficerNational Board Of Health Mar 2012 - May 2012Vigilance casesMonitor notified bodiesRegistration of manufacturers and devices (EUDAMED)Free sales certificatesEtc. -
Akademisk Sagsbehandler / Scientific OfficerDanish Medicines Agency May 2008 - Feb 2012Academic in product safety within medical devices -
Akademisk MedarbejderStatens Serum Institut Mar 2008 - May 2008Academic research position within genetics
Merete Yde Skills
Merete Yde Education Details
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Biology -
Haslev GymnasiumMatematisk
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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