2013-2014 QP and QA Scientist, CMC Biologics A/S
QP release of API and Drug Products
Batch record review,
Master Production record review
Audits, Lead Auditor
CAPA, Deviations, Change Request
API biotechnology,
Cell banks MPRs and release of cell banks
2012-2013 GMP Specialist, GXP PharmAid ApS,
Consulting
Audits
Preparation and review of Quality Agreements
Batch record review for clinical trial packaging
CAPA handling.
Annual Product review
2008-2012 GMP and Production Specialist, Region Zealand, Hospital Pharmacy,
Introduction of an electronic production system in the Cytostatic department.
Qualification and validation of production systems.
Release of products.
Contact to physicians and nurses working with oncology
2006-2008 QA Manager, Linde Gas Therapeutics/AGA
Audits
QP-delegated release of products
Quality management
1999-2006 GMP Auditor, H. Lundbeck,
Audits
QP delegate, release of products for clinical trials
Approval of validation and qualification protocols and reports
Release of packaging and raw materials for clinical trials
Approving master documents and specification for conventional and biotech products
1991-1999 QA Specialist and Production Development Chemist Novo Nordisk A/S,
Audits
Master batch record approval
Batch review
QP delegated release of products for clinical trials
Approval of validation and qualification protocols and reports
Approval of SOPS for laboratories
Handling of complaints
New product formulation
Approving master documents and specification for conventional and biotech products
1982-1991 QA/QC-manager, University State Hospital Pharmacy, Copenhagen.
Released products from production, sterile and conventional
Master record approval
Analytical and batch record review
Analytical testing and validation