Brussels Metropolitan Area
I love to keep on learning and improving my soft and hard skills. I am a team player who can easily collaborate and provide support. My calm demeanor is a great asset during stressful and challenging periods. In the coming years, I'd like to get more expertise in areas like radio-pharmaceuticals, medical devices and audit/inspections.
IDB Holland BV is a manufacturing site that produces Radioligand Therapies (RLT)
- Qualified Person (Investigational medicinal Products & Advanced Therapy Medicinal Product) - Subject Matter Expert Medical Devices (implementation of EU MDR 2017/745) - Oversight of Third Parties - GDP Responsible Person - Audit and Inspection Readiness
- Guarantee pharmaceutical quality of all Novartis Pharma products on the Belgian and Luxembourgian markets - Define, implement, maintain and control the quality system - Management of market's complaints - Answer quality related questions - Artwork approval for commercial products and label text approval for clinical trial material - Follow-up of all the Belgian and European pharmaceutical legislation aspects - Ensure cGMP and GDP inspections
- Review, Approval and Release of IMP's batch record - Review, Approval and Release of clinical trial labels - Ensure compliance with Belgian regulatory requirements, GMP and GCP - Interact with CRA and Regulatory department
- Discover new cultures - Practice my Spanish - Pursuit of my dreams