Scientific Quality Assurance Specialist
1 week ago
This is a one-year temporary position in the QC Stability Team within the Quality Control department at AGC Biologics. The team handles stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. As a key member of the team, you will collaborate with stakeholders to ensure smooth project execution.
The successful candidate will be responsible for:
- Preparing and reviewing Change Control, Deviation, and CAPA documents
- Developing and reviewing customer-specific stability protocols and reports
- Collaborating with customers on stability-related topics
- Overseeing testing at external laboratories
- Maintaining cGMP compliance with relevant guidelines (EU, FDA)
The Department
You will join a highly dedicated team of scientists and technicians in the QC laboratory, working closely with QC Support which 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 experience in quality control or assurance. The ideal candidate should possess:
- Sound knowledge of drug substance/drug product stability and cGMP
- Experience handling change controls, deviations, and CAPAs
- Knowledgeable of chromatographic and bioassay methods
- Excellent communication skills in English
- Demonstrated ability to drive continuous improvement and/or productivity programs
- Team player with the ability to work independently
The successful candidate should thrive in a challenging and dynamic environment, enjoy a rapid pace of work, and possess a positive attitude with a good sense of humor.
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