About the QC Compliance Support Team
The core tasks in QC Compliance Support Team evolves around GMP compliance and includes several challenging and fun tasks such as managing and writing QC change controls both for internal changes and changes coming from our customers, coordinating and writing lab exceptions (OOS/OOT) and QC deviation investigations and CAPA´s.
Furthermore, we prepare quality data for metrics and review meetings, and hold some customer contact responsibilities. We provide support for internal audits and inspections as well as support to the rest of the QC organisation and other departments on site.
About Quality Control Department
Our Quality Control (QC) department at site Hillerød consists of approximately 225 employees divided into five testing teams and five support teams. QC department supports manufacturing on site and act as a CLO. We test drug substance, drug product, finish goods, all the raw materials used in the onsite manufacturing processes as well as stability samples.
Besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. We also have a canteen arrangement incl. Friday brunch and monthly afternoon cake. As a company we strive against being the best place to work with also focus on maintaining a healthy working environment.
Role Responsibilities:
- Drive and coordinate QC change controls, deviations, and lab exceptions with relevant stakeholders and subject matter experts.
- Maintain GMP documentation in collaboration with stakeholders and QA.
- Prepare performance KPI data and participate in review meetings.
- Identify and implement process optimization opportunities.
- Engage in new tasks arising from our site's expansion over the coming years.
Preferred Qualifications:
- Experience with cGMP and pharmaceutical manufacturing.
- Background in managing GMP deviations, OOS/OOT, change controls, and CAPAs.
- Experience in CMO/CDMO/CLO roles, or QC/QA positions.
- Academic degree or relevant education/experience.
- Self-driven, systematic, with a knack for improving processes.
- Open to changes and keen on personal and professional development.
- Strong communication and collaboration skills.
- Familiarity with QC data systems (e.g., LIMS) and metrics tools (e.g., Tableau) is a plus.
- Proficiency in English. While not mandatory, proficiency in Danish is desirable
At FUJIFILM Diosynth Biotechnologies we care about developing our employees so when you start working with us, you are not just starting a new job, but kick starting your career. As employee in QC Lab Support, we provide you with a variety of development options in a busy and changing environment.
Your Application
If you find the job interesting and it fits your qualifications, please upload your CV and cover letter as soon as possible as we will process the applications as they arrive.
We offer
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.
How to apply: Directly at the following website
https://fujifilmdiosynth.wd3.myworkdayjobs.co m/External/job/Hillerod/Scientist-for-QC- Compliance-Support_JR2958