Quality Assurance Professional in QA Operations Drug Product team, Hillerød, Denmark
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Hillerød
Do you want to have an extensive influence and add your footprint on our future Drug Product Facility at FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD)? Do you have experience within the Fill Finish area and aseptic processing?
We are looking for an experienced QA colleague to join our newly formed QA DP operations team. First part of the journey will be joining the project phase of our future DP facility and in close collaboration with the QA team play an important part of our Operational readiness, ensuring a DP facility fully operational and in compliance.
About FUJIFILM Diosynth Biotechnologies
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. 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 Department
The QA Operations Department within FDBD is a larger team around 80 employees. Together, we shape the QA mindset for the future and the work environment is informal and with a good sense of humor, while keeping a high pace. In QA we support each other and we have an open and honest communication within the team. The QA DP ops team is based under the Finished Goods & Drug Product organization, having sister QA ops teams supporting the Finished Goods Operations at FDBD.
About the Role
As a QA Professional in our QA DP team you will support the project’s phase “Operational Readiness” and after facility commissioning and IQ/OQ/ PQ you will continue working in the team who will have Quality Oversight of the DP facility operations (including managing deviations and change controls) and all other Quality related activities. Performing review and QP release of DP batches may be potential future work tasks. Building relationships with customers and internal cross-functional teams is one of your strengths and with your aseptic filling / DP experience, you will bring deep knowledge to the team and stakeholders outside QA. Your Emotional Intelligence (EQ) is valued, being a team player, keeping calm at navigating ambiguity or during a shorter period with competing priorities.
Job Tasks
Qualifications
We are looking for a candidate with the following background and skill sets:
Personal skills
As a person you approach tasks and colleagues with openness and great energy. You possess an analytical mindset and understand the importance of involving stakeholders in your daily work. You are self-starting and have a flexible, dynamic approach to work. You are a strong team player.
Your application
Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis and will take down the advert when we have found the right candidate:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Quality-Associate-in-QA-Operations-Drug-Product-team_JR1337
In case you have any questions or doubts, please do not hesitate to reach out to Manager in Quality Assurance Marianne Ingvardsson on [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
We are looking for an experienced QA colleague to join our newly formed QA DP operations team. First part of the journey will be joining the project phase of our future DP facility and in close collaboration with the QA team play an important part of our Operational readiness, ensuring a DP facility fully operational and in compliance.
About FUJIFILM Diosynth Biotechnologies
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. 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 Department
The QA Operations Department within FDBD is a larger team around 80 employees. Together, we shape the QA mindset for the future and the work environment is informal and with a good sense of humor, while keeping a high pace. In QA we support each other and we have an open and honest communication within the team. The QA DP ops team is based under the Finished Goods & Drug Product organization, having sister QA ops teams supporting the Finished Goods Operations at FDBD.
About the Role
As a QA Professional in our QA DP team you will support the project’s phase “Operational Readiness” and after facility commissioning and IQ/OQ/ PQ you will continue working in the team who will have Quality Oversight of the DP facility operations (including managing deviations and change controls) and all other Quality related activities. Performing review and QP release of DP batches may be potential future work tasks. Building relationships with customers and internal cross-functional teams is one of your strengths and with your aseptic filling / DP experience, you will bring deep knowledge to the team and stakeholders outside QA. Your Emotional Intelligence (EQ) is valued, being a team player, keeping calm at navigating ambiguity or during a shorter period with competing priorities.
Job Tasks
- Support FDBD’s DP project of the “Operational Readiness” to ensure a compliant DP facility will be ready and pass the qualifications. This is done within a larger project team already established at FDBD today
- Bring Quality and GMP knowledge to the project team meetings and challenge the status quo.
- Project QA tasks may be very broad, supporting the different needs from the organization to ensure the proper processes are setup and described in procedures
- Once the DP facility is operational the role of the QA Associate will change to having more routine tasks of various QA related tasks to support the DP manufacturing.
- Quality oversight of the DP facility
- Managing change controls, deviations, documentation updates etc.
- Perform batch record review
- Perform batch QP release
- QA customer relations
Qualifications
We are looking for a candidate with the following background and skill sets:
- Bachelor’s (BA) or Master’s Degree (MSc) Physical, Chemical or Biological Science, Technical Engineering or equivalent
- Ideally +5 years of experience of aseptic manufacturing, preferably from QA
- Deep cGMP knowledge
- Good communication skills and fluency in English
Personal skills
As a person you approach tasks and colleagues with openness and great energy. You possess an analytical mindset and understand the importance of involving stakeholders in your daily work. You are self-starting and have a flexible, dynamic approach to work. You are a strong team player.
Your application
Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis and will take down the advert when we have found the right candidate:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Quality-Associate-in-QA-Operations-Drug-Product-team_JR1337
In case you have any questions or doubts, please do not hesitate to reach out to Manager in Quality Assurance Marianne Ingvardsson on [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 "Biolog", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 9.5.2022, 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.
- Biolog
- Hillerød
- Mandag den 04. juli 2022
Lignende jobs
-
Biolog i Hillerød
Få mere info- Biolog
- Hillerød
-
Biolog i Nordsjælland
Få mere info- Biolog
- Nordsjælland
-
Biolog i Klampenborg
Få mere info- Biolog
- Klampenborg
Statistik over udbudte jobs som biologer i Hillerød
Herunder ser du udviklingen i udbudte biolog i Hillerød over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal biologer.
Se flere statistikker her:
Statistik over udbudte biologer i Hillerød over tid
| Dato | Alle jobs som biologer |
|---|---|
| 2. juli 2024 | 1 |
| 1. juli 2024 | 1 |
| 30. juni 2024 | 1 |
| 29. juni 2024 | 1 |
| 28. juni 2024 | 1 |
| 27. juni 2024 | 1 |
| 26. juni 2024 | 1 |