- In this position, you are responsible for planning and execution of daily quality documentation while ensuring compliance with all existing GMP and safety standards in the area of responsibility.
- You will work in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine.
- The Quality Assurance Associate works with autologous and allogeneic cell products in accordance to GMP guidelines.
Tasks and results:
- Generate, revise, review control, archive and process of controlled GMP documentation.
- SOP’s, manufacturing and quality Batch Records, validation of protocols and reports, non-conformities, change requests).
- Monitor compliance with all applicable GMP and safety standards.
- Administrating and reporting progress on the Quality Key Performance Indicators (QKPI) in a QRB setting, such as Non-Conformances, Change control and CAPAs.
- Acting as assigned QA core team member in company projects.
- BSc degree in Life Sciences- biochemistry, biology or biotechnology with relevant experience in a GMP related industry is required.
- Good knowledge of cGMP regulations, preferably in Advanced Therapeutic medicinal Products (ATmPs) and the current Industry Standards.
- Good communication skills in English.
- Demonstrated proficiency in MS Office.
- Accuracy, tidiness, self-organized, flexible, attention to detail, team player.