Shire QA System Professional II in Lessines (Baxalta), Belgium
Develop, Manage, Analyze and assure follow up of metrics related to Quality Systems including Change Control, Exception Management (GEMS) in alignment with global and site requirements
Develop tools to analyze and share Quality System metrics within Lessines organization and to support actions’ identification in order to maintain satisfactory metrics
Participate to global meetings concerning IT solutions linked to Quality Systems metrics
Work in close collaboration with Lessines’ Execution leads for Exception Management (GEMS) and Change Control and with global quality data analyst
Train on Quality Systems metrics.
Participate actively to Quality System activities related to Exception Management (GEMS), Change Control, Quality Risk Management and Quality Management Review System
Participate actively to continuous improvement projects related to Quality Systems.
Support inspections conducted by Health Authorities, Customers and License Partners.
Bachelor degree or equivalent
5+ years’ experience in Quality or Manufacturing of biotech or pharmaceutical products
Excellent knowledge of Microsoft Excel, good knowledge of other Microsoft applications
Feel at ease with IT applications
Knowledge of Quality System process
Communication skills with teams, peers, global partners
Good English knowledge
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.