FUJIFILM: Quality Assurance Professional in QA Operations Drug Product team

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

• 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.

In case you have any questions or doubts, please do not hesitate to reach out to Manager in Quality Assurance Marianne Ingvardsson on marianne.ingvardson@fujifilm.com

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.