Copenhagen, Capital Region of Denmark, Denmark
I am a pharmacist with a master degree and have an academic background within pharmaceutical sciences, including pharmaceutical aspects of drug manufacturing. Concretely, I am qualified to independently handle related tasks in planning, conducting and taking responsibility for drug production, quality assurance, registration and marketing of drugs. I have excellent knowledge about pharmaceutical manufacturing technologies, with special focus on drug formulation, production and quality assurance with respect to the appropriate regulatory requirements. Personally, I am good at working using my own initiative or as a part of a team due to my good collaboration and communication skills. Being personally committed and highly motivated to solving problems in a positive and flexible manner, I can assure high quality operations within assigned deadlines. I have developed a pragmatic approach to my assignments with focus on quality and patient safety.
- Head of quality ensuring maintenance of Quality Management System and being in compliance with the regulatory requirements of GDP, GMP, Euphoriants and Medicinal Cannabis - Acts as the Qualified Person (QP) in compliance with Eudralex vol. 4 annex 16 and current Danish regulatory requirements - Acts as the Competent Person (CP) in compliance with the Danish regulatory requirements - Acts as the Responsible Person in compliance with the Danish executive order on distribution of medicinal products and GDP guideline (2013/C 343/01) - Responsible for inspections conducted by the Danish Medicine Agency, including routine inspections and approval of a completely new facility holding GMP, GDP, Euphoriants and Medicinal Cannabis authorizations - Leading external/internal audits
Project management, coordination, validation of equipments Planning, organising and reporting projects Laboratory work with UPLC and UV spectrophotometer Working with GMP rules and compliance Presentation to other colleges and teams
Development of the training system Review, write and update SOP’s (NC and CAPA) Support the team on daily work Implementing new training processes for departments Updating and simplifying the workflow for departments HR and QC Participate in workshops and giving ideas to improve better results
Leading the younger staff at work Planning the day at work for the team Development of the sales methods and presenting them to meetings for the team Motivating the team to improve their work Helping the staff to develop on their work Training of new staff
Advising patients and healthcare professionals about drug use Quality assurance and control of prescriptions Improve workflow efficiency through LEAN tools Documentation and development of strategies