Experience

BHS Logistics

• Denmark
• Transportation, Logistics, Supply Chain and Storage
• 100 - 200 Employee

• QA Manager

  • Jan 2023 - Present

  Sjælland, Danmark



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Associate I, Quality Assurance

  • Mar 2018 - Jan 2023

  Region Hovedstaden, Danmark • Delegated Qualified Person: Disposition of commercial finished products to global markets as delegated QP. • Co-Auditor: Audit and inspection of Supplier/Service Provider • Quality Lead on Supply Chain including internal/external Warehouse and Logistics within GMP, GDP area. • Co-Project Manager: Driving the implementation of Change Control process from Biogen to Fujifilm. • SME & QA ‘Ambasador': SME & ‘Ambassador’ within the QA area including cross-functional projects… Show more • Delegated Qualified Person: Disposition of commercial finished products to global markets as delegated QP. • Co-Auditor: Audit and inspection of Supplier/Service Provider • Quality Lead on Supply Chain including internal/external Warehouse and Logistics within GMP, GDP area. • Co-Project Manager: Driving the implementation of Change Control process from Biogen to Fujifilm. • SME & QA ‘Ambasador': SME & ‘Ambassador’ within the QA area including cross-functional projects and close collaboration with QA Program Manager & Lead Program Manager. • Partner Assessor: Assessing changes with potential impact on customer based on Quality Agreements • Global Change Controls: Assessment, Approval & General Support • Market, Customer and Supplier Complaints: Handling, assessment and optimization. • Review and assessment of Deviations and CAPAs • cGMPs and Regulatory requirements • Improvement and updates related to systems, documentations, procedures etc:

• Associate III, Delegated QP, Quality Assurance

  • Jun 2017 - Jan 2023

  Region Hovedstaden, Danmark • Delegated Qualified Person: Disposition of commercial finished products to global markets as delegated QP. Participation in coordination of timely batch disposition for finished products commercial disposition including close collaboration and daily contact to the Label & Pack department. •QA Product Responsibility of Tysabri®: Representative of QA • Global Change Controls: Assessment, Approval & General Support • Review and assessment of deviations, CAPA etc:… Show more • Delegated Qualified Person: Disposition of commercial finished products to global markets as delegated QP. Participation in coordination of timely batch disposition for finished products commercial disposition including close collaboration and daily contact to the Label & Pack department. •QA Product Responsibility of Tysabri®: Representative of QA • Global Change Controls: Assessment, Approval & General Support • Review and assessment of deviations, CAPA etc: Reviewing deviations (Events, Planned Exceptions and Investigations) in connection to batch disposition. • cGMPs and Regulatory requirements: Ensuring that Biogen products are manufactured in accordance with their licenses, cGMP and with all regulatory requirements in all markets served. • Improvement and updates related to systems, documentations, procedures etc:

• Associate III, Quality Assurance Biogen (Full Time Employee)

  • Jan 2017 - Jan 2023

  Region Hovedstaden, Danmark • Global Change Controls: Assessment, Approval & General Support • Annual Product Review (APR), Management Report and Deviation Trending: Origination, coordination and preparation of presentations of information on departmental performance and site quality performance over pre-defined time period on pre-set dates and on request (Quaterly Quality Management Report, Site Management Review, Deviation Trending, Department Data and Ad.Hoc Reports. • Assessment and approval of… Show more • Global Change Controls: Assessment, Approval & General Support • Annual Product Review (APR), Management Report and Deviation Trending: Origination, coordination and preparation of presentations of information on departmental performance and site quality performance over pre-defined time period on pre-set dates and on request (Quaterly Quality Management Report, Site Management Review, Deviation Trending, Department Data and Ad.Hoc Reports. • Assessment and approval of deviations, CAPA etc: Assessment and approval of Events, Investigations and Planned Exceptions. • cGMPs and Regulatory requirements: Ensuring that Biogen products are manufactured in accordance with their licenses, cGMP and with all regulatory requirements in all markets served. • Improvement and updates related to systems, documentations, procedures etc:

• Associate III Quality Assurance (Contractor)

  • Apr 2016 - Dec 2016

  • Annual Product Review (APR), Management Report and Deviation Trending: Origination, coordination and preparation of presentations of information on departmental performance and site quality performance over pre-defined time period on pre-set dates and on request (Quaterly Quality Management Report, Site Management Review, Deviation Trending, Department Data and Ad.Hoc Reports. • Project: Risk Based Approach, Control Strategy • QA Review of Production Batch Records: QA review of… Show more • Annual Product Review (APR), Management Report and Deviation Trending: Origination, coordination and preparation of presentations of information on departmental performance and site quality performance over pre-defined time period on pre-set dates and on request (Quaterly Quality Management Report, Site Management Review, Deviation Trending, Department Data and Ad.Hoc Reports. • Project: Risk Based Approach, Control Strategy • QA Review of Production Batch Records: QA review of batch documentation for commercial finished products, preparing of all release documentations including certificates for final review and disposition by the Delegated Qualified Person. • Review and completion of PDAs in relation to Technical Product Complaints: Deviation reviews and review of batch production records. • Review of deviations, CAPA etc: Reviewing deviations (Events, Planned Exceptions and Investigations) in connection to batch disposition. • cGMPs and Regulatory requirements: Ensuring that Biogen products are manufactured in accordance with their licenses, cGMP and with all regulatory requirements in all markets served. • Participation in internal/external Inspections and Audits: Support to backoffice in relation to Audits with different Ad.Hoc tasks. • Improvement and updates related to systems, documentations, procedures etc:



FUJIFILM Diosynth Biotechnologies

• United Kingdom
• Biotechnology Research
• 700 & Above Employee

• Senior Associate I

  • Aug 2019 - Dec 2022



Høng Apotek

• Stud.Pharm

  • Feb 2014 - Jul 2014

  Centervej 35, 4270 Høng Kommunikation og formidling, analysearbejde, statistisk arbejde Communication, analytical and statistical tasks.



Topsoe

• Denmark
• Chemical Manufacturing
• 700 & Above Employee

• Studentermedhjælper

  • Dec 2011 - Aug 2013

  Heimdalsvej 4-6, 3600 Frederikssund Laboratorieassistent i QA/QC-afdelingen. Deadlineorienteret produkttest, batchfrigivelse, SAP, optimering af eksisterende analysemetoder og SOP'er, LEAN, CAPA, kvalitetssikring og kvalitetskontrol af produkter, bestilling af udstyr samt kemikalier. Laboratory assistant in QA/QC department. Deadline orientated product test, batch release, SAP, optimization of existing analyse methods and SOPs, LEAN, CAPA, quality assurance and quality control of products, ordering equipment and… Show more Laboratorieassistent i QA/QC-afdelingen. Deadlineorienteret produkttest, batchfrigivelse, SAP, optimering af eksisterende analysemetoder og SOP'er, LEAN, CAPA, kvalitetssikring og kvalitetskontrol af produkter, bestilling af udstyr samt kemikalier. Laboratory assistant in QA/QC department. Deadline orientated product test, batch release, SAP, optimization of existing analyse methods and SOPs, LEAN, CAPA, quality assurance and quality control of products, ordering equipment and chemicals. Show less



Mødrehjælpen

• Denmark
• Non-profit Organizations
• 100 - 200 Employee

• Callcenteragent (phoner)

  • Jun 2010 - Nov 2010

  Nørre Voldgade 80, 1358 København K Indsamling af økonomisk støtte og lettere rådgivning via telekommunikation. Collecting economical subsidy and lightly advising through telecommunication.



Tranberg + Partners

• Interviewer/Dataindsamler

  • May 2006 - Apr 2007

  Ragnagade 7, 2100 København Dataindsamler, interviewer, mødebooker samt rekruttering. Indsamling af data via telefoninterview, personlig rekruttering og analyse af data heraf. Formidling af information samt resultater. Gathering data, interviewer, booking meetings and recruiter. Gathering data through teleinterviews, face to face personal recruitment and analysing the gathered data. Promotion of information and obtained results.



Vanløse pizzaria & restaurant

• Tjener

  • Oct 2003 - Apr 2006

  Jernbane Allé 70, 2720 Vanløse Tjener Waiter