Quality Control Analyst
2 weeks ago
Job Description
You will be a key member of the QC Stability Team, contributing to the stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your primary responsibility will be to work closely with stakeholders such as customers, project managers, management, your own department, and QA to identify and manage analytical stability packages needed for projects.
Your tasks will include:
- Reviewing and developing customer-specific stability protocols and reports
- Collaborating with customers on stability-related topics
- Evaluating compliance with relevant cGMP guidelines (EU, FDA)
About Our Team
You will join the QC Support team in the QC laboratory, where you will work with highly dedicated scientists and technicians. The QC Support department consists of three teams: QC Raw materials, QC Samples & Service, and QC Stability.
About the Ideal Candidate
We are seeking an MSc holder in Biochemistry, Pharmaceutical Sciences, or a related field with relevant experience in quality control or quality assurance. In addition to this, we expect the ideal candidate to possess some of the following skills and qualifications:
- Strong knowledge of DS/DP stability and cGMP principles
- Experience in managing change controls, deviations, and CAPAs
- Knowledge of chromatographic and bioassay methods
- Excellent communication skills in English, both spoken and written
- Demonstrated ability to drive continuous improvement and productivity programs
- A team player with the ability to work independently
The ideal candidate will thrive in a challenging environment and enjoys a dynamic pace of work. They bring a positive attitude and a good sense of humor.
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