Shire R&I CI Coordinator in Lessines (Baxalta), Belgium
Support Receiving and Inspection activities of raw materials in order to ensure the product quality and the compliance to GMP, regulations and SOPs.
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
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
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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.