Position Overview
F or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI.
The key tasks are :
Operations:
Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities, including:Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirementsManagement and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departments Release of API batches:
GMP and Quality Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and...