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 PharmaCell 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.