You take full responsibility as Qualified Person (QP) for our European production facility located in Schelle, as well as for two other sites (with limited activity) managed remotely. As the key Quality contact on site, you are responsible for batch release, ensuring strict adherence to Good Manufacturing Practice (GMP) guidelines and regulatory requirements.
In this role, you drive key pharmaceutical projects on-site, including the validation of new manufacturing processes, new analytical methods, and the introduction of new products. You lead and empower a dedicated team of 7 people (Backup QP, QC Officer, Lab Team Leader, Lab Technicians…) who assist you in daily release activities, deviation management, Out of Specification (OOS) investigations, customer complaints, self inspections, as well as equipment/instrument qualification and process validation.