Ensures integration and support of quality regulations: drug, biologics, device and/or combination products.
Work independently, review and authorize to sale final product based on approved processes and European and local regulation.
Assist in the design of effective quality systems, procedures and/or processes within the commercial QA Western Europe organization that should be suitable for Belgium commercial office.
Assist in assessing current QA processes and procedures at the Belgium affiliate identifying as applicable improvement opportunities
Partner, coordinate and support activities related to product actions in the affiliate.
Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
Support the Belgium Responsible Person to coordinate and investigate quality events such as deviations, non-conformances, product quality complaints and corresponding action plans including decisions.
Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
Master degree of pharmacist or master in pharmaceutical sciences, medical doctor or master in medical sciences, veterinary or master in the veterinary sciences, chemist or master in chemistry, biologist or master in biology, biomedical scientist or master in the biomedical sciences.
5+ years’ experience in quality assurance, quality oversight or relevant experience.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
Strong computer skills and knowledge of standard enterprise QA IT systems.
Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
Strong oral, written communication and presentation skills. Proficiency in Dutch/French/English.