Scientist for QC Change management Support
4 months ago
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 change controls 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
Fujifilm Diosynth Biotechnologies Denmark is expanding, and so is our QC Change Management team. Our team of five enthusiastic colleagues are eager to welcome a new member to our vibrant group. Whether you bring relevant background in GMP, ideally from previous QC or QA roles, or a deep interest in quality and compliance, we are excited to meet passionate individuals ready to contribute to our dynamic workplace. If you’re ready to take your career to the next level, we want to hear from you
About the Quality Control Department
Located in Hillerød, our Quality Control department comprises approximately 230 employees across five testing teams and five support teams. We support onsite manufacturing as well as act as a Contract Laboratory Organization (CLO), testing drug substances, drug products, finished goods, stability samples, and all raw materials used in manufacturing.
About the QC Change Management Support Team
The QC Change management Support Team is integral to our GMP compliance efforts and handles a variety of tasks including:
- Managing QC change records for both internal and customer-initiated changes
- Engaging with a wide network of colleagues, teams, and partners, providing a dynamic and diverse work environment
- Coordinating and documenting changes to our quality processes in a controlled way
- Managing customer contacts in relation to change records, supporting internal audits and inspections, and providing assistance across the QC organization and other departments onsite
About the Role
- Drive and coordinate QC change controls, with relevant stakeholders and experts
- Build lasting relationships across various departments and external partners
- Maintain GMP documentation in collaboration with stakeholders and QA
- 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
- Skilled in managing GMP change controls and/or CAPAs
- Prior roles in CMO/CDMO/CLO or QC/QA
- Academic degree or relevant training/experience
- Self-motivated and systematic, with a strong attitude for clear documentation of process improvements
- 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 fitness center
- Remote work options
- 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
Your Application
If you are interested in this role and meet the qualifications, please submit your CV and cover letter as soon as possible. We review applications on a rolling basis.
Location: FDBD Hillerod
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