Denmark
Quality Management Systems | Life Science Pharmaceuticals & Medical Device | GMP/ GDP | Project Management
As a Adv. QA professional at Novo Nordisk, I ensured the quality and compliance of bulk manufacturing of HRT products through hands-on oversight and collaboration across teams. QA Oversight: Monitored production processes on-site at Måløv, ensuring quality and cGMP compliance at all stages. QP Delegate – Batch Release: Managed the batch release process, ensuring products met regulatory standards before market release. Cross-functional Collaboration: Partnered with production, regulatory, and R&D teams to ensure seamless operations and compliance. Compliance & Deviation Management: Addressed deviations, ensured internal and external cGMP compliance, and implemented corrective actions. Document Approval: Reviewed and approved key documents, including deviations, CAPA reports, and batch records. Process Optimization: Simplified processes and identified improvements to enhance efficiency and maintain compliance. Key Achievements: Ensured quality and compliance by approving batch release documentation and clearing products for market. Supported the successful release of HRT products in compliance with internal and external quality standards.
GDP Deputy, Management Representative Deputy, Certified Investigator, Project Management, Nordic QMS Responsible, Internal and External Auditor Subject Matter Expert (SME) in GDP, EN-ISO 13485:2016, and Novartis/Alcon requirements SME for the improvement of procedures and documentation systems Responsible for non-conformities and CAPAs Responsible for planning and performing internal audits as a Lead Auditor Responsible for the Supplier Qualification Program, evaluating GxP suppliers and service providers SME in preparation for external audits: Notified Body and Health Authorities Managing all quality-related activities in the Nordic affiliate, ensuring compliance with applicable regulatory standards and global requirements. Develop and execute strategies for quality oversight in the Nordic affiliate. Led significant improvements in the quality management systems, quality team, and collaboration with partner functions, strengthening the robustness of the QMS and enhancing GDP and ISO audit preparedness of the Nordic organization during a period of significant organizational changes.
QA- Quality Assurance •Supporting activities involving Quality Management Systems as such as review and update of procedures. • Supporting distribution activities with the 3rd party warehouse (Good Distribution Practices), this includes working in close collaboration with Manufacturing sites, warehouse and Nordic wholesales to ensure proper documentation available for release of the pharmaceutical products (including but not limited to CoAs, CoCs, etc). • Responsible for handling of temperature deviations and other transport deviations. • Collecting and preparing monthly Key Performance Indicators (KPIs) reports. • QA oversight and follow up of non-conformities, which includes follow up with CAPA owners, reporting, archiving. Work together with the areas to implement corrective and preventive actions. • Support continuous improvement projects (implementation of DCM and Plateau). • Supporting preparation of audits (internal and external) and inspections by Health Authorities (HA).
Pharmaceutical Design & Development, Analytical Support
Clinical Pharmacy: To gain Jus practicandi. Throughout this internship I worked closely together with medical doctors (and other health care professionals as well). My communication skills across different areas of expertise were enhanced and I got hands on experience with analyzing patients treatment - beeing able to recommend adaptations.