Delegated QP/experienced QA Associate for QA Drug Substance, Hillerød, Denmark (JR1732)
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Hillerød
Are you a skilled and experienced Quality Assurance specialist eager to join a fast-growing CDMO? Apply for this position where you will be an important part of developing and ensuring our quality aspiration.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.
About the Role
You will take on a role as a QA partner for all activities related to Drug Substance Manufacturing activities, daily operations, optimization projects, expansion programs and partner collaborations.
About the Department/Team
You will be part of the QA DS QP team. Currently the team consists of 6 dedicated QP’s that covers the Drug Substance Manufacturing operation and project activities, along with project related expansion activities. An independent and dynamic team in daily contact and in close collaboration with all internal stakeholders and QA colleagues.
Job Responsibilities
Your primary tasks will be:
Qualifications
We are looking for a candidate with the following background and skill sets:
Personal qualifications
Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/da-DK/External/job/Delegated-QP-experienced-QA-Associate-for-QA-Drug-Substance_JR173
Should you have any questions, please feel free to reach out to Manager in QA, Christina Schmidt at [email protected]
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.
About the Role
You will take on a role as a QA partner for all activities related to Drug Substance Manufacturing activities, daily operations, optimization projects, expansion programs and partner collaborations.
About the Department/Team
You will be part of the QA DS QP team. Currently the team consists of 6 dedicated QP’s that covers the Drug Substance Manufacturing operation and project activities, along with project related expansion activities. An independent and dynamic team in daily contact and in close collaboration with all internal stakeholders and QA colleagues.
Job Responsibilities
Your primary tasks will be:
- To perform batch review and release activities, ensuring the batch has been manufactured and tested in accordance with accordance with GMP regulations, quality agreements and Marketing Authorizations.
- Take on the QA role in technical transfer operations and approval of related change controls and documents.
- To help maintain the quality system related to the exceptions and disposition processes based on the current GMP, GDP and regulatory requirements.
- To adhere to the quality system and support the Drug Substance Manufacturing organization in appropriate handling of exceptions.
- You will also support the quality assurance department with all relevant tasks, that being approval of procedures, deviations, change controls, CAPAs etc.
- Assessing changes related to partner programs, to ensure a proper review of such changes for impact to regulatory requirements and quality agreement.
Qualifications
We are looking for a candidate with the following background and skill sets:
- Professional qualifications
- University degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry or biology
- Knowledge of GMP quality systems and legislation.
- High-Quality mind-set
- You have a high level of business perspective
Personal qualifications
- Service minded
- Proactive in your approach
- Able to work independently
- A team player
- Thrive in a changing environment
- Enjoy working with multiple stakeholders in a large organization
Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/da-DK/External/job/Delegated-QP-experienced-QA-Associate-for-QA-Drug-Substance_JR173
Should you have any questions, please feel free to reach out to Manager in QA, Christina Schmidt at [email protected]
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 7.11.2022, 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.
- Apoteker
- Hillerød
- Mandag den 02. januar 2023
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