Consultant

• Sep 2020 - Present

Design Control Specialist

• Nov 2019 - Aug 2020

Facilitated the Design Control deliveries in R&D Sales Projects Planned project DHF documentation deliveries and ensured timely deliveries Design Input - Traceability Matrix Planned and executed technical design reviews, as well as Design Freeze & Design Transfer Reviews Writing and updating of other relevant design documentation deliveries as; General Product Safety Requirements, List of Standards, Rationals Facilitated the Design Control deliveries in R&D Sales Projects Planned project DHF documentation deliveries and ensured timely deliveries Design Input - Traceability Matrix Planned and executed technical design reviews, as well as Design Freeze & Design Transfer Reviews Writing and updating of other relevant design documentation deliveries as; General Product Safety Requirements, List of Standards, Rationals

Associate Scientist - Product and project supporter

• Jun 2017 - Nov 2019

Supplier visits & assessment -Assessment of test houses for design verification of pre-filled syringes -Review of supplier DHF documentation (for product parts) -Assessment of device parts & suppliers for potential new parts Design Verification on Device Constituent part of Combination Products & Packaging Materials -Design Verification Plan -Test method development & qualification -Development of fixtures for testing -Writing Protocols, Reports and Summaries -Performed testing & trained laboratory technicians Risk management -Workshops for dFMEcA -User insights for User Task Analysis and uFMEcA Process Mapping & Analysis Mapped the QMS described complaint process through the company Interviewed relevant stakeholder Reporting and presentation of improvement plan Gap analysis on DHF documentation for legacy products APQR Review of device constitutive part of combination product - complaints -Risk management - NCs/CAPAs -Change controls -AEs (from Pharmacovigilance) Show less

Process Support

• Jun 2015 - May 2017

In my current position as Process supporter on the full automatic material handling system and warehouse (25A, Hillerød) my key tasks are: - Monitoring of Warehouse temperatures with weekly reviews - Support the Project Office with info due to processes, procedures, risk assessment and system documentation - Perform system reviews and baselines on the material handling system an the warehouse - Use A3 as a systematic problem solving tool - Handling of Change Request (CR) - Writing /improving Standard Operating Procedures (SOP) - Secure cGMP-compliance and continuously develop and improve quality - Handling of Non Conformities (NC) - Supports technicians and operators with daily challenges Show less

Supply Chain Assistant

• Feb 2012 - Mar 2014

Problem solving Quality control of weapons and ammunition Implementation of the recycling program in the department Handling customer complaints Armory responsible: Coordination of delivery of arms, munitions and sensitive materials Planning of maintenance and preparation for intern audits Planning and coordination of order fulfillment, receiving, delivery and shipping. Inventory management, registration and counting in SAP. Security responsible for products labeled as environmental hazard due to regulations. Show less

Supply Chain Operations

• Jun 2013 - Jul 2013

Summerjob Batch and consumption registration in SAP. Localised products and made on time delivery for the production lines. Worked with SAP Warehouse, kaizen and lean 5S. Summerjob Batch and consumption registration in SAP. Localised products and made on time delivery for the production lines. Worked with SAP Warehouse, kaizen and lean 5S.

Production Assistant

• Apr 2008 - Jan 2011

I was a part of the production team which were responsible for the production, packing and shipping of Bøllinge bakkeborde, Rosendahls Aben, Bjørnen og Elefanten. I was a part of the production team which were responsible for the production, packing and shipping of Bøllinge bakkeborde, Rosendahls Aben, Bjørnen og Elefanten.

Student Assistant

• Jan 2005 - Jul 2005

Benni Winding Hansen, Hans Ramløv og Valery Forbes. Research; Growth and hatching assays of copepod eggs. This work resulted in an article published in the Oxford Journal. Collection of Tardigrates. Planning the student's contribution to the Festival of Research, Ro's Torv. Various office duties. Benni Winding Hansen, Hans Ramløv og Valery Forbes. Research; Growth and hatching assays of copepod eggs. This work resulted in an article published in the Oxford Journal. Collection of Tardigrates. Planning the student's contribution to the Festival of Research, Ro's Torv. Various office duties.