Qualified person (QP) for Aseptic Manufacturing in Gentofte

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Gentofte

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. Working at [xxxxx] [xxxxx] is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 61,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at [xxxxx], we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing. Contact For further information, please contact Quality Director Ditte Kivsmose Kaldor at +[xxxxx]or [xxxxx] . Deadline 24 October 2024 To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 11.10.2024, men kan have været deaktiveret og genaktiveret igen.

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