Qualified person
2 months ago
Are you a skilled QA specialist with experience from pharmaceutical industry, preferable within aseptic manufacturing, who is eager to set direction and to ensure compliance to the right level? Do you thrive in a constantly changing environment with various challenges and find it rewarding to develop colleagues?
Then you can become the new Qualified Person (QP) in our area – apply today
The position
You will be appointed as QP for Aseptic Manufacturing in Gentofte with responsibility for release of drug products for the market, and hereby appoint and support the QP delegates and other colleagues in the department.
As a QP, you will set the direction for quality in our area, ensuring highest quality to the patients in a changing and challenging environment. You will be key person in the department and contribute with expertise in larger and complex quality issues, where you will be involved approval of escalated deviations from line of business and act as a resource for colleagues with less experience. You will also be deeply involved in audits and inspections in the area.
To succeed in your role, you will be proactive and be able to see challenges and solutions from a holistic view to create the best solutions for the area and across boundaries to other sites. In your role, you will refer directly to the Director for the department, Product Supply (PS) Aseptic Manufacturing (AM) QA in Gentofte.
Qualifications
We seek a colleague who fits our organisation both professionally and personally. As a person you are open minded with high level of energy, an outgoing attitude and have very strong communication and collaboration skills with both your colleagues in QA, line of business and site management.
To succeed in this role, you should have:
an academic degree within MSc in Pharmacy, veterinarian or similar, this to ensure fulfil the requirements from the Danish Medicine Agency to become “Qualified Person”.
solid experience within the pharmaceutical industry, and a 5+ years of experience with quality assurance and production. Experience within aseptic production will be considered an advantage for this position.
substantial experience in release of drug product and/or finished product.
scientific, systematic, and logic-driven approach
proven experience in effectively identifying and managing risks within aseptic manufacturing operations to ensure the safety, quality, and efficacy of aseptically manufactured products.
demonstrated ability to collaborate and communicate effectively within a complex stakeholder environment, ensuring alignment and engagement across boundaries in the organisation.
About the department
Our department is acting as quality support for all Aseptic production in Gentofte, where medicine is produced in a sterile environment for people living with serious chronic diseases. We bring value to our patients by assuring safe and high-quality products in accordance with Good Manufacturing Practice (GMP). The department are currently growing to support our production facilities located in Gentofte and consists of more than 70 highly qualified employees led by an engaged and experienced leadership team. You will be a part of a department where behavioural targets are driving our culture and where setting direction for quality is driven through quality oversight and our ability to support and drive improvements. We are producing at full speed on existing lines while building and ramping up new state of the art facilities.
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