Scientist, Quality Control Specialist
2 weeks ago
The Role
You will be part of the Quality Control team at AGC Biologics, handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day will involve ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA.
Your responsibilities will include:
- Writing and reviewing CR, Deviations, and CAPA documents
- Writing and reviewing customer-specific stability protocols and reports
- Engaging with customers regarding stability topics
- Overseeing testing at external laboratories
- Ensuring cGMP compliance with relevant guidelines (EU, FDA)
The Department
You will be part of the QC Support team in the QC laboratory, working alongside highly dedicated scientists and technicians. QC Support consists of three departments: QC Raw materials, QC Samples & Service, and QC Stability.
The Ideal Candidate
We are looking for an MSc holder in Biochemistry, Pharmaceutical Sciences, or a relevant area, with preferably work experience within quality control or quality assurance. The ideal candidate should bring sound knowledge of stability of DS/DP and cGMP, experience handling change controls, deviations, and CAPAs, and knowledge of chromatographic and bioassay methods.
The ideal candidate should also be able to communicate clearly in English, both in speech and writing, and have demonstrated experience in driving continuous improvement and/or productivity programs. Additionally, the ideal candidate should be a team player combined with the ability and desire to work independently.
Location
Copenhagen Site
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