Shire QA System Professional II in Lessines (Baxalta), Belgium

Responsibilities

  • 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.

Profile

  • 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

  • Organizational skills

  • Autonomous

  • 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.