Promethera Biosciences is an international biotech company with headquarters in Belgium and US operations in North Carolina, developing innovative therapies for the treatment of liver diseases. Its proprietary cell-based technology platforms are based on mature hepatocytes and allogenic progenitor cells isolated from healthy adult human liver donors. Promethera Biosciences is today close to market with Heparesc, in clinical stage with HepaStem and in pre-clinical stage with H2Stem.
If you are sharing our vision of the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for inborn and acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 50 people, consider joining our fast growing company.
Promethera Biosciences is currently hiring a Quality Assurance Specialist.
- Maintains and improves product quality and ensures continuous improvements by managing change controls, deviations, OOS, CAPA, Quality risk assessment
- Manages and reviews documents of Promethera quality system
- Participates in the reception and release process of raw materials and consumables
- Organizes and takes part to suppliers’ and service providers’ qualification / auditing
- Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing monitoring procedures, corrective/preventive actions, and verification procedures
- Reviews batch records and qualification/validation reports
- Participates in the release and shipping processes of the finished product
- Participates in the process of reception/qualification/release of equipment
- Performs Annual Quality Reviews
- Is present on the ground for assisting day to day critical operations
- Checks logbooks
- Performs internal audits
- Master degree in sciences or relevant experience in a similar position in the sector of biotech/Pharma/cell therapy. Qualified Person certification is a real plus.
- Good knowledge of cGMP
- Experience of minimum 4-5 years in Quality Assurance, preferably in a biopharmaceutical company
- Experience in cGMP audits
- Experience in cell therapy or quality control of human cells is a real plus
- Fluency in French and English professional proficiency
- Computer skills (Windows environment)
- Rigorous, passionate and dynamic
- Hands-on problem solving and proactive attitude
At our headquarters in Mont-Saint- Guibert, Belgium
You may apply for this position by sending your CV and application letter to email@example.com
Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.