Merete Yde Email & Phone Number

Nordsjælland

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.

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.

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...

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

Rødovre

Pharmocovigilance/Vigilance (adverse events etc)ComplaintsPSUR submittalsTeaching vigilance proceduresMaintaining and updating vigilance procedures

Vigilance casesMonitor notified bodiesRegistration of manufacturers and devices (EUDAMED)Free sales certificatesEtc.

Academic in product safety within medical devices

Academic research position within genetics

Cand.Scient, Biology

Biologist

Studentereksamen, Matematisk