About
With abackground in chemical engineering from the Technical University of Denmark and more than 12 years experience working in the pharmaceutical industry in roles such as QC-chemist, QA-specialist, Responsible Person, Qualified Person and Quality Manger, I understandthe flow between the vital parts of your business - from quality assurance to production and daily operations.
As aconsultant to your business, my primary focus is to ensure solid, pragmatic and effective solutions in quality control and assurance activities. My experience with the rules and guidelines of the industry, and the possibilities within these, allows me to help you find the solutions that best suit your needs.
I offer my services in all aspects of quality control and assurance, both as the primary in charge of QA and QC, or as secondary in the role of mentor to junior QA or junior QC or as assistance to your primary QA or QC.
Services
I operate form my address in Aarhus, and take on roles on-site, remote or a combination, depending on location and type of service.
Examples of services:
- In-house GMP/GDP training (for junior level QA/QC)
- Temporary assistance in QA/QC
- Troubleshooting – laboratory testing and equipment
- Method development – QC
- Method validation – QC
- Equipment qualification – QC and production
- Process validation
- Self inspection GMP
- External audit API/production sites
- Compilation of existing validations/qualifications, recommendations of additions
- Review of the QMS for potential gaps
- Module 3 (MA), project phase, obtaining material, reading through and proofreading.
The list is not exhaustive and depends on the scope of the individual tasks. Do not hesitate to contact me for clarification.
C.V
Employment:
2024 -
Independent consultant, Sloth Møller Pharma Consult
2022 - 2024
QA/QC Manager and Competent Person Little Green Pharma (Cannabis regulation)
Responsible for managing the QA and QC department. Including responsibility for GMP quality audits by customers, sub-contractors, authorities and self inspection. Implementing and maintaining QMS in a young and international pioneer company.
2019 - 2022
Quality Assurance and Quality Control Manager, Pharma Nord ApS
Which additionally includes responsibility for the QC chemist team.
2017 - 2022
Responsible Person, Pharma Nord Norge AS
Responsibel for the QMS and inspections by The Norwegian Medicines Agency for GDP compliance.
2016 - 2022
Quality assurance Manager, Pharma Nord ApS
Which additionally includes responsibility for the QA team, support to relevant departments especially regulatory affairs during the marketing authorizations process of new products, and maintenance of existing products.
2013 - 2022
QP, Pharma Nord ApS
06 June 2013 approved as Qualified Person by the Danish Medicines Agency, for release of Pharma Nords pharmaceutical products to the designated marked.
Including responsibility for GMP quality audits of API suppliers, sub-contractors and authorities. Approving change controls, qualifications and validations.
2011 - 2013
QC – Chemist, Pharma Nord ApS
Including responsibility for approving analytical results, trouble shooting, change control handling, equipment qualification and method validation.
2005 - 2011
Sales Engineer, G&S
Responsible for sales, support, CE-marking and documentation of valves, motors, actuators and pumps for the chemical industry and power plants.
Education:
1999 - 2005
Cand. Polyt – Applied Chemistry andChemical Engineering, Technical University of Denmark (DTU)
Relevant courses (2011 - 2024):
- Quality Risk Management
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GMP for technicians
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Pharmacovigilance – introduction
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GDP – pharmaceutical products
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EU GMP rules – requerments and implementation
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Toxicology
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Formulation of pharmaceuticals
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Validation of analytical methods
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Qualification of analytical equipment
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Validation of production methods
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Qualification of production equipment
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Production of investigational products –GCP