
Quality Control Specialist II
2 weeks ago
Be part of an exceptional story in Brnik (Slovenia) We're establishing a state-of-the-art center for the production of sterile biosimilar medicines, powered by the latest technology to deliver high-quality, affordable biosimilar medicines to patients worldwide. Join the team that's shaping the future of pharmaceuticals—today.
Responsibilities
- Implementation of a new analytical technique for testing medical devices (autoinjectors).
- Manage OOx / analytical deviations and complaints.
- Ensure all activities in compliance with cGxP, and with data integrity. Perform Quality Control (QC) oversight activities.
- Maintain and calibrate equipment including plan preparation.
- Review and approval of analytical tests (analytical release), materials and product.
- Interpretation and reporting of results and analysis of trends.
- Participation within the validation, transfer and management of issues related to analytical methods and techniques in accordance with requirements.
- Responsible for the creation and revision of standard operating procedures (SOPs), Certificate of analysis (CoA), analytical and registration documentation
- Support laboratory associates in their daily tasks and troubleshooting.
Qualifications
- University degree in pharmacy, chemistry or any other natural science degree.
- Preferred experience in production, development or other quality functions on expert position.
- Knowledge of English.
- Knowledge of Microsoft Office.
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