Customer Program Quality Scientist
4 days ago
Customer Program Quality Scientist
Customer Program Quality ScientistApply locations Hillerod posted on Posted 30+ Days Ago job requisition id JR3339
Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level to our customers and keep them updated around the manufacturing of their products? Then you might be the key person we are looking for
Come and join the Program Quality Management team for Manufacturing (PQM MFG) at FUJIFILM Diosynth Biotechnologies and play an important role in the relationship with our customers. With a fast-expanding site, our team is growing to support our increased number of customers. The PQM MFG team is accountable for the communication of all quality related topics affecting customer’s programs for production of Drug Substance, Drug Product and Finished goods. The communication is based on the responsibilities defined in Quality Agreement (QUAG).
About the Position
We work with various biopharma companies, which means each project we work on brings a unique set of challenges. As a Customer Program Quality Scientist, you are a link between our customers and our FDB team.
You will be involved in different quality related topics affecting customer’s programs and make sure customers are informed and involved to feel confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. You will take part in identifying opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers.
Job Responsibilities
Your primary tasks:
- Be the primary point of contact to customers regarding assessment and communication on Deviations, Change Controls and CAPAs and various ad hoc requests.
- Perform impact assessments of change controls and deviations towards Quality Agreement requirements.
- Prepare KPI data for Quality Management Review meetings and other reporting structures.
- Establish, develop and maintain department documents: customer presentations, SOPs and participate in our internal Continuous Improvement activities.
- Ad hoc tasks.
Professional and Personal Qualifications
The candidate should hold a bachelor or master degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 2 years of relevant QA experience. As a person you approach tasks and colleagues with openness and great energy. You possess a structured mindset and understand the importance of involving stakeholders in your daily work. You are a self-starter and have a flexible, dynamic approach to work. You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471.
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