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 2025 strategy, which aims to accelerate our impact in innovative therapeutics.
You will become part of the Development QA team which ensures 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 medical devices for injectable treatments in collaboration with external partners. Your role in this new 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 Ensure quality agreements are followed and 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 moving into new ground – injection devices in partnership development – and 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 and IT QA department will consist of 10 great QA colleagues, 3 working with IT projects, 5 with drug development 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 and Global Quality Business Partner).
The position is placed in the LEO Pharma headquarters in Ballerup.
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 2025 strategy, which aims to accelerate our impact in innovative therapeutics.
You will become part of the Development QA team which ensures 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 medical devices for injectable treatments in collaboration with external partners. Your role in this new 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:
Your qualifications
As LEO Pharma is moving into new ground – injection devices in partnership development – and 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 and IT QA department will consist of 10 great QA colleagues, 3 working with IT projects, 5 with drug development 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 and Global Quality Business Partner).
The position is placed in the LEO Pharma headquarters in Ballerup.
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 31.1.2020, 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 23. februar 2020
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