Shire Senior Quality Validation in Lessines (Baxalta), Belgium
The Senior Quality Validation is responsible to support quality review of equipment, cleaning, and process or automation system validation at the Lessines Bioscience facility. The position may focus on Bulk Manufacturing, Finishing and Packing.
Manage the quality validation activities for big/ strategic projects including the supervision of others Quality Validation members, the respect of timeline and the respect of budget
Assist the Quality Validation Lead
Review/approval of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ) to ensure compliance to procedures and regulatory requirements.
Review and approve test incident occurred during the validation in a quality perspective
Participate and approve the risk analysis linked to validation activities in a quality perspective.
Review/approval of periodic review of critical system to ensure compliance to procedures and regulatory requirements.
Collaboration and participation in projects as Quality Representative for Validation. Provide quality guidance for the development of the validation approach. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
Take part in internal and external audits.
BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline.
Minimum 3 to 5 years in Validation/ or quality systems.
Critical thinking and problem solving
Uncompromising dedication to quality
Able to work in a multi-disciplinary team environment.
Fluent in English (spoken/ written)
Familiar with Quality Management and GxP Regulations, especially in validation.
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.