PIC/S COMPLIANCE EXPERT
Il y a 3 mois
Kontich, Flanders, Belgique
LabLife
Temps plein
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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.
• 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.