Are you ready to join Bioporto in introducing a life-saving medical device to the US market?
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Hellerup
Are you an experienced QA Validation Specialist with knowledge of validation in a medical device environment?
BioPorto has approximately 30 dedicated employees globally, most of whom work at their beautiful headquarter in Hellerup. With a roll up your sleeves attitude and loving the collaborative work environment, their size is a strong point, and you will quickly get to know the whole office along with your new US-colleagues, who comes by on a regular basis adding to the global twist to BioPorto's international team of colleagues in the Production.
In BioPorto they are focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management.
You will play a key role in defining and continuously updating the validation strategy at BioPorto, together with QA.
If you're ready for a challenge that can make a real difference, apply to be QA Validation Specialist!
Key Responsibilities:
As a QA Validation Specialist, you will play a vital role in ensuring that everything meets the necessary regulations and standards.
You'll need to monitor validated processes to make sure everything is running smoothly and ensure that the Validation Master Plans (VMPs) are always up to date. You'll work closely with other teams to plan and execute the qualification and validation of our equipment, software, and processes.
You'll also perform internal and external audits and present the validation and quality assurance processes to auditors. This is critical in ensuring that BioPorto is following all the necessary regulations and guidelines, through training of colleagues.
Furthermore, the position relies on you to:
Your Qualifications
We need someone with a degree in engineering, biotechnology, or something similar, who knows about making sure things are qualified and validated. Preferably, you should also understand standards for quality systems, medical laws, and be able to speak and write in English on a professional level.
It will also be an advantage if you have:
Your personality is a good team player that is helpful, takes charge of solving problems, and thrives working in a changing and developing environment. It is important, that you are willing to go the extra mile to help your colleagues.
Practical information
For connectivity and day-to-day contact, when not in the same location, BioPorto uses Teams and expect you to be proactive and use the media when needed.
Based in Tuborg Havn in ‘the Cube’ you will enjoy the light office space, the great canteen and hopefully participate in the shared ‘walk post lunch’ around the harbor area. BioPorto's organization can be characterized as energetic, passionate and committed to providing a supportive work environment.
Apply for the job
If the above has caught your interest, apply for the position by submitting an updated CV and a motivated application. You can also include a brief bio in the application text above. This recruitment is handled by Temp-Team A/S, and all inquiries must go through Temp-Team.
Temp-Team
Temp-Team A/S er et landsdækkende rekrutterings- og vikarbureau med lokale afdelinger i Danmark.
Vi har 40 års erfaring inden for personaleløsninger og dækker et bredt udsnit af brancher. Vi yder altid en service af høj kvalitet og har tæt personlig kontakt til både vores kandidater og kunder.
Vi er en del af JuhlerGroup – en international koncern.
Kilde: Jobnet.dk
BioPorto has approximately 30 dedicated employees globally, most of whom work at their beautiful headquarter in Hellerup. With a roll up your sleeves attitude and loving the collaborative work environment, their size is a strong point, and you will quickly get to know the whole office along with your new US-colleagues, who comes by on a regular basis adding to the global twist to BioPorto's international team of colleagues in the Production.
In BioPorto they are focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management.
You will play a key role in defining and continuously updating the validation strategy at BioPorto, together with QA.
If you're ready for a challenge that can make a real difference, apply to be QA Validation Specialist!
Key Responsibilities:
As a QA Validation Specialist, you will play a vital role in ensuring that everything meets the necessary regulations and standards.
You'll need to monitor validated processes to make sure everything is running smoothly and ensure that the Validation Master Plans (VMPs) are always up to date. You'll work closely with other teams to plan and execute the qualification and validation of our equipment, software, and processes.
You'll also perform internal and external audits and present the validation and quality assurance processes to auditors. This is critical in ensuring that BioPorto is following all the necessary regulations and guidelines, through training of colleagues.
Furthermore, the position relies on you to:
- QA Release of products for packaging and sale
- Participate in the company's transition to new European rules under IVDR
- Be part of the implementation of Master Control as new IT tool for the Validation area
Your Qualifications
We need someone with a degree in engineering, biotechnology, or something similar, who knows about making sure things are qualified and validated. Preferably, you should also understand standards for quality systems, medical laws, and be able to speak and write in English on a professional level.
It will also be an advantage if you have:
- Knowledge of qualification and validation, both in theory and practical experience
- Knowledge of GMP
- Knowledge of Quality Systems Standards ISO13485, FDA CFR21 part 820 and IVD/Medical legislation
Your personality is a good team player that is helpful, takes charge of solving problems, and thrives working in a changing and developing environment. It is important, that you are willing to go the extra mile to help your colleagues.
Practical information
For connectivity and day-to-day contact, when not in the same location, BioPorto uses Teams and expect you to be proactive and use the media when needed.
Based in Tuborg Havn in ‘the Cube’ you will enjoy the light office space, the great canteen and hopefully participate in the shared ‘walk post lunch’ around the harbor area. BioPorto's organization can be characterized as energetic, passionate and committed to providing a supportive work environment.
Apply for the job
If the above has caught your interest, apply for the position by submitting an updated CV and a motivated application. You can also include a brief bio in the application text above. This recruitment is handled by Temp-Team A/S, and all inquiries must go through Temp-Team.
Temp-Team
Temp-Team A/S er et landsdækkende rekrutterings- og vikarbureau med lokale afdelinger i Danmark.
Vi har 40 års erfaring inden for personaleløsninger og dækker et bredt udsnit af brancher. Vi yder altid en service af høj kvalitet og har tæt personlig kontakt til både vores kandidater og kunder.
Vi er en del af JuhlerGroup – en international koncern.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 10.5.2023, 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.
- Produktspecialist
- Hellerup
- Torsdag den 01. juni 2023
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