Scientist for QC Compliance Support
Employer: FujiFilm
Location: Hillerod
Join Our Growing Team at Fujifilm Diosynth Biotechnologies Denmark.
We are thrilled to share that Fujifilm Diosynth Biotechnologies Denmark is expanding, and so is our QC Compliance Support team. Our team of thirteen dynamic professionals is eager to welcome a new member with a background in GMP, ideally from previous QC or QA roles, or someone with proven experience in change management combined with a deep interest in quality and compliance. Take this opportunity to manage, coordinate and lead Change Controls in QC in a supportive and knowledge-sharing environment.
So, are you looking for an exciting new opportunity with a fast-growing company that values your work-life balance and well-being? Take this opportunity to manage Compliance Support Tasks within QC with a friendly and engaging team, and enjoy a competitive salary, a flexible workspace with remote work options, on-site massage sessions, access to a modern fitness center, and many other employee benefits. We can’t wait to meet you and help you settle in!
About the Quality Control Department
Located in Hillerød, our Quality Control department comprises approximately 260 employees across five testing teams and five support teams. We support onsite manufacturing with testing of drug substance and raw materials used in manufacturing, testing stability samples and testing of drug products and finished goods manufactured external.
About the QC Compliance Support Team
The QC Compliance Support Team is integral to our GMP compliance efforts and handles a variety of tasks including:
- Managing and writing QC Change Controls for both internal and customer-initiated changes.
- Coordinating, writing and documenting lab exceptions (OOS/OOT) and QC Deviation Investigations
- Preparing quality data for metric analysis and review meetings.
- Supporting customer contacts, supporting internal audits and inspections, and providing assistance across the QC organization and other departments onsite.
About the Role
- Drive and coordinate change controls with relevant stakeholders and experts.
- Maintain GMP documentation in collaboration with stakeholders and QA.
- Prepare and present performance KPI data in review meetings.
- Identify and execute process optimization opportunities.
- Take on new tasks linked to our site’s expansion in the coming years.
Preferred Qualifications:
- Experience in cGMP and pharmaceutical manufacturing.
- Proficient in managing Change Control records.
- Prior roles in CMO/CDMO/CLO or QC/QA.
- Academic degree or relevant training/experience.
- Self-motivated and systematic, with a strong aptitude for process improvement.
- Adaptable, with a focus on personal and professional growth.
- Excellent communication and collaboration skills.
- Familiarity with QC data systems (e.g., LIMS) and metrics tools (e.g., Tableau) is a plus.
- Proficiency in English; Danish proficiency is a plus but not required.
We Offer
- A competitive salary and bonus package.
- Benefits including health insurance, massage and physiotherapy, health checks, and a fitness center.
- Remote work options.
- Recently added amenities like a mobile barista coffee van.
- Canteen services including Friday brunch and monthly afternoon cake.
- A commitment to creating the best workplace environment, focusing on health and well-being.
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