Qualified Person (Medicines for animal use)
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Hellerup
Contura International A/S is a Copenhagen based medical technology company that develops, manufactures and commercializes soft tissue fillers based on proprietary hydrogel technology. The facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products.
The company offers
A challenging position in a growing company with dedicated people and a strong pioneer spirit. We reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.
There is a natural focus on the ongoing development of professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.
We are a team of 10, reporting to the Director of QA, and we are looking for the right colleague to add additional competencies to the team and Contura
The position
As a QP, you will be responsible for delivering best-in-class quality assurance of our manufacturing processes and products.
You will be offered the opportunity to be approved QP for the Vet products, which is classified as pharma products. In addition, the production facility is enlarged and you will be involved in the development of this.
In your daily work you will challenge and approve documents in connection with development, manufacture, and release of batches produced in the production facility.
In addition, you will be a part of our development projects ensuring our products are following the information provided to Health Authorities worldwide. Furthermore, you will – in close cooperation with your colleagues – identify and contribute to strengthening compliance of our production facilities level and act as a consultant for them.
Professional profile/qualifications
Personal Profile
Contura
The company’s development, manufacturing and testing processes comply with the European Medical Devices Directive/Regulation and the European good manufacturing practice for medicines for animal use. The quality system meets the standards required to obtain ISO 13485:2016.
Application
Applications will be reviewed on an ongoing basis. For further information, please contact Hanne Beirholm, Beirholm Search at 29440080.
The company offers
A challenging position in a growing company with dedicated people and a strong pioneer spirit. We reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.
There is a natural focus on the ongoing development of professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.
We are a team of 10, reporting to the Director of QA, and we are looking for the right colleague to add additional competencies to the team and Contura
The position
As a QP, you will be responsible for delivering best-in-class quality assurance of our manufacturing processes and products.
You will be offered the opportunity to be approved QP for the Vet products, which is classified as pharma products. In addition, the production facility is enlarged and you will be involved in the development of this.
In your daily work you will challenge and approve documents in connection with development, manufacture, and release of batches produced in the production facility.
In addition, you will be a part of our development projects ensuring our products are following the information provided to Health Authorities worldwide. Furthermore, you will – in close cooperation with your colleagues – identify and contribute to strengthening compliance of our production facilities level and act as a consultant for them.
Professional profile/qualifications
- You hold a MSc in pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology
- You have solid experience with GMP and quality assurance, you come from a similar position where you see this as an add on to next step.
- Experience with qualification activities in production is an advantage
- You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity
- Experience with medical device GMP and quality assurance is an advantage
- Project management experience is an advantage
- Fluent in Danish and English required (oral and writing)
Personal Profile
- Strong team player
- Enjoy problem solving and capable of thinking out-of-the-box
- You have the ability to work intensively in teams and with external parties while maintaining independence and integrity
- As a small and tightly knit team with a bit of a family atmosphere, we would like you to be an honest, supportive and loyal member
- You are receptive to new opportunities and sustainable solutions
- You are well structured and meet deadlines
- A sense of humor will go a long way
- You are as a person curious and interested in market demands and developments, requirements and standards issued by competent authorities.
Contura
The company’s development, manufacturing and testing processes comply with the European Medical Devices Directive/Regulation and the European good manufacturing practice for medicines for animal use. The quality system meets the standards required to obtain ISO 13485:2016.
Application
Applications will be reviewed on an ongoing basis. For further information, please contact Hanne Beirholm, Beirholm Search at 29440080.
Hanne Beirholm
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 10.3.2023, 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.
- Øvrige
- Hellerup
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