Quality Expert in biopharmaceutical drug substance development
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Ballerup
Be our expert and expand your knowledge
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 and IT QA team which ensures LEO Pharma’s development products and QMS continuous to be 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
The job is a new position established to strengthen LEO Pharma’s knowledge within biopharmaceutical drug substance manufacture and testing for use in clinical trials.
LEO Pharma outsource manufacturing of investigational medicinal products (IMP) which means your collaboration partners are internal development departments, other quality departments as well as external partners.
You will be part of establishing a solid baseline knowledge of biopharmaceutical drug substance manufacture and testing in Development & IT QA. At the same time you will get the opportunity to broaden your knowledge into other parts of IMP development and manufacture as you will be trained to work as QA for development in projects covering chemical drug substances, tablets, creams, solution for injection and/or pack and label. You will also act as qualified person for IMP.
LEO Pharma operates within a wide range of formulations manufactured at contract manufactures both in Europe and outside of Europe. Our QMS needs to be robust and simple and clearly define roles and responsibilities. This is a task we continually work on and in which you will have a significant role.
In the job, you will:
Act as qualified person performing batch certification of investigational medicinal products, including biopharmaceutical drug substance Act as project QA for development projects covering drug substance, drug product, testing and the packed and labelled IMP Act as GMP support to development departments Drive and support a robust QMS for development and certification of IMP
Up to 10 days travel may be required yearly.
Your qualifications
Academic degree – e.g. pharmacist or engineer 8+ years of experience from the pharmaceutical industry Solid and up-to-date knowledge of Biopharmaceutical Drug Substance manufacture and GMP requirements Experience in working with Investigational Medicinal Products
You are open-minded, well organized, independent and have a good analytical sense. You approach your tasks meticulously, and you are attracted by the opportunity to use your quality management skills in a company, which is moving into new fields. You see opportunities – in projects and in the collaboration with your colleagues.
The position requires you are proficient in English and speak Danish.
Your new team
The Development and IT QA department will consist of 10 great QA colleagues, 3 working with IT projects, 2 with device development and 5 of them – including you - working within drug development.
We are striving to safeguard our patients and to improve the quality of our processes.
We focus on developing our competencies 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.
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 and IT QA team which ensures LEO Pharma’s development products and QMS continuous to be 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
The job is a new position established to strengthen LEO Pharma’s knowledge within biopharmaceutical drug substance manufacture and testing for use in clinical trials.
LEO Pharma outsource manufacturing of investigational medicinal products (IMP) which means your collaboration partners are internal development departments, other quality departments as well as external partners.
You will be part of establishing a solid baseline knowledge of biopharmaceutical drug substance manufacture and testing in Development & IT QA. At the same time you will get the opportunity to broaden your knowledge into other parts of IMP development and manufacture as you will be trained to work as QA for development in projects covering chemical drug substances, tablets, creams, solution for injection and/or pack and label. You will also act as qualified person for IMP.
LEO Pharma operates within a wide range of formulations manufactured at contract manufactures both in Europe and outside of Europe. Our QMS needs to be robust and simple and clearly define roles and responsibilities. This is a task we continually work on and in which you will have a significant role.
In the job, you will:
Up to 10 days travel may be required yearly.
Your qualifications
You are open-minded, well organized, independent and have a good analytical sense. You approach your tasks meticulously, and you are attracted by the opportunity to use your quality management skills in a company, which is moving into new fields. You see opportunities – in projects and in the collaboration with your colleagues.
The position requires you are proficient in English and speak Danish.
Your new team
The Development and IT QA department will consist of 10 great QA colleagues, 3 working with IT projects, 2 with device development and 5 of them – including you - working within drug development.
We are striving to safeguard our patients and to improve the quality of our processes.
We focus on developing our competencies 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.
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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