Shire R&I CI Coordinator in Lessines (Baxalta), Belgium

Summary

Support Receiving and Inspection activities of raw materials in order to ensure the product quality and the compliance to GMP, regulations and SOPs.

Responsibilities:

  • Lead the changes related to raw material process (materials, procedures,…)

  • Act as owner of local specifications

  • Act as a coordinator of deviations related to raw materials (root cause analysis, impact evaluation, action definition,…)

  • Support R&I activities related to “QC inspected materials” and to “controlled supplies” (SNC agreement, SCAR,…)

  • Lead continuous improvement projects related to Material

  • Support R&I activities and ensure the release of the material in timely manner and in strict compliance with GMP, SOP and regulations (release, IPSO evaluations, reduced testing,proofreader,…).

  • Act as a backup for the R&I coordinator

Profile

  • Knowledge quality systems, scientific background

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

  • Ability to work in a multi-disciplinary team environment

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

  • Good organizational, planning and communication skills

  • Learning attitude and continuous improvement mindset

  • Computer skills: MS Office (advanced knowledge in Excel is a plus), JDE, Trackwise

  • Master Degree in Science

  • Pharmacist/QP (Qualified person in Belgium) is a plus

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.