Shire Qualified Person in Lessines, Belgium

  • Act as QP for ensuring that the manufacturing , testing , labeling and packaging are in compliance with GMP and requirements of Marketing Autorization:

  • Perform on time the batch release certification of raw materials, intermediates and final products, in compliance with EU guidelines and MOH requirements

  • Sign and update the release product registers

  • Handle legal retention samples (sampling, storage, destruction)

  • Review and approve Annual Product Quality Review

  • Review and approve major product complaints

  • Act as QP for IMP / clinical studies according to EU Annex 13 guidelines

  • Be the contact Person of the Belgium Authorities (AFMPS)

  • Review of change controls and communicate to AFMPS if needed

  • Act as QP in Shire Global QP meetings

  • Review and approve release, product specifications, documentation,… through the appropriate system, per Annex 16

  • Participate to audits with authorities from various countries

  • Support the implementation of projects for e.g. launches of new products and/or geographies, QC changes methods/ tests in alignment with MOH requirements/ certification,…

  • Redact declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes, clarification etc..)

  • Perform gembas & take part in the improvement of internal processes

  • Training and coaching of delegate QP’s and interns

  • Contribute to the quality department’s activities to ensure continuity of activities

  • Represent Baxalta Belgium Manufacturing S.A. through Baxalta QP network and through VAPI


  • At least 5 year experience in a similar function

  • Registered Qualified person in Belgium : certified by AFMPS (Belgian royal decree of Dec 2006 art 48)

  • Knowledge of quality systems, EU and FDA regulations, cGMP, GDP, Eudralex, Annex 16, Annex 13

  • Fluent in French and English (spoken and written knowledge)

  • Ability to manage priorities /

  • Ability to work in a multi-disciplinary team environment

  • Fact-based / Critical thinking / Rigor / autonomy / proactivity / Stress-resistant

  • Good organizational, planning and communication skills

  • Learning attitude and continuous improvement mindset

  • Computer skills: MS Office

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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.