PIC/S COMPLIANCE EXPERT

Il y a 2 mois

Kontich, Flanders, Belgique LabLife Temps plein
We are looking for PIC/S Compliance Experts who will guide and support hospital pharmacies and healthcare organizations in their journey toward PIC/S compliance, ensuring that infrastructure, processes, and quality systems meet international Good Practice (GxP) standards. Your Role As a PIC/S Compliance Expert, you will play a key role in helping hospitals and healthcare organizations implement and maintain quality systems that align with PIC/S and GxP requirements. You’ll support teams in building compliant, efficient, and inspection-ready operations, bridging the gap between regulation and daily practice. Your Role May Include Performing gap analyses to assess current practices and identify areas for improvement. Supporting the setup or revision of Quality Management Systems (QMS), including procedures for change control, deviations, and CAPA. Writing and reviewing qualification and validation protocols for equipment and controlled environments. Managing or supporting project delivery, from planning and coordination to implementation and follow-up. Assisting with the development of training systems and quality awareness within hospital teams. Supporting internal audits, inspection preparation, and continuous improvement initiatives. Translating regulatory requirements into clear, practical procedures adapted to hospital workflows. Collaborating with multidisciplinary teams to embed a sustainable quality culture. Qualities You have a Master of Science (Pharmaceutical Sciences, Biomedical Sciences, Bio-Engineering, Chemistry, etc.) or equivalent experience. You have experience in a GxP or healthcare environment (hospital pharmacy, production, quality, or validation). You understand quality systems, validation, and compliance frameworks. You speak Dutch and English fluently, French is a plus. Additional assets You work well independently and in a team. You have an eye for detail and structure. You communicate clearly and adapt easily to your audience. You are customer-focused and enjoy a hands-on, consultancy approach. You like to share knowledge and help others grow.