Quality Expert in injection device development
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Ballerup
Be part of the future in device development
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have an ambitious 2030 strategy, which aims to accelerate our impact in innovative therapeutics.
You will become part of the Development Quality, Devices team. We ensure LEO Pharma device development products are in compliance with regulatory requirements.
The job will offer you opportunity for personal as well as professional growth and for making a significant difference for people with serious skin diseases all over the world.
The job
LEO Pharma develops combination products and medical devices for injectable treatments in collaboration with external partners. Your role in this position is to act as project QA working with our internal R&D as well as external partners. One of your essential tasks is to ensure alignment between the established contracts and the development documentation.
You can look forward to being involved in interesting development projects such as electronic needle free injection device and pre-filled syringes.
You will
- Ensure regulatory compliance in the development projects
- Establish quality agreements
- Ensure quality agreements are followed
- Set direction within Human factors engineering and usability studies, Product risk management, Design verification and validation, Design transfer, Product maintenance.
- Ensure internal compliance for documentation such as specifications, plans, protocols/reports and customer complaints
- Support maintenance of design history files for new as well as established products.
- Additionally, support a robust QMS within injection device development
Your qualifications
- Academic degree – e.g. engineer
- 8+ years of experience from the pharmaceutical industry
- Solid and up-to-date knowledge of EMA and FDA regulatory requirements within injection devices
As LEO Pharma is on new ground – injection devices in partnership development – our processes are currently being established or matured. Therefore, you must thrive in an environment where you often are challenged on what is the best and achievable solution in a given project. You will need to actively seek input for the best solution and to communicate clearly. Collaboration is the key to success.
The position requires you are proficient in English and speak Danish.
Up to 10 days travel may be required yearly.
Your new team
The Development Quality department will consist of 11 great QA colleagues, 3 working with GCP and GLP, 6 with drug development GMP and 2 - including you - with device development.
We are striving to safeguard our patients, to improve the quality of our processes and to meet the need of the patients and our stakeholders, internally as well as externally. We are driven by integrity and compliance. In our team, we discuss and investigate to find the best solutions for our patients, for LEO and our colleagues.
Beside our stakeholders, we collaborate closely with other functions within Global Quality (e.g. Global Quality Audits, External Manufacturing and Suppliers Quality).
The position is placed in the LEO Pharma headquarters in Ballerup.
Contact and application
If you have questions, please do not hesitate to contact Louise Groth Persson, Senior Manager, at + 45 5380 0591.
Please apply via the link at our website where application and CV is attached. The deadline is 15.08.2021. We read applications continuously, and vacancies may be filled sooner than the deadline, so apply as early as possible.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,400 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 2.7.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Ballerup
- Søndag den 15. august 2021
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