Shire Qualified Person in Lessines (Baxalta), 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

Profile:

  • 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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.