- Managing and drafting QC change controls for both internal and customer-initiated changes.
- Coordinating and documenting lab exceptions (OOS/OOT) and QC deviation investigations and CAPAs.
- Preparing quality data for metric analysis and review meetings.
- Managing customer contacts, supporting internal audits and inspections, and providing assistance across the QC organization and other departments onsite.
- Drive and coordinate QC deviations, lab exceptions(OOS/OOT), CAPAs and 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.
- Experience in cGMP and pharmaceutical manufacturing.
- Proficient in managing GMP deviations, OOS/OOT, change controls, and CAPAs.
- 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.
- A competitive salary and bonus package.
- Benefits including health insurance, massage and physiotherapy, health checks, and a fitness center.
- Work from home options
- 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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Scientist for QC Compliance Support - Hillerød, Danmark - FUJIFILM Diosynth Biotechnologies
Beskrivelse
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 team. Our team of seven dynamic professionals is eager to welcome a new member with a background in GMP, ideally from previous QC or QA roles, or someone with a deep interest in quality and compliance. Take this opportunity to manage OOS/OOT, change controls, deviations, and CAPAs in a supportive and knowledge-sharing environment.
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 a Contract Laboratory Organization (CLO), testing drug substances, drug products, finished goods, all raw materials used in manufacturing, and stability samples.
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:
About the Role
Preferred Qualifications:
We Offer
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.
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 Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. 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.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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.
Location: FDBD Hillerod
