Jiva de Vetter, MSc.

Personal Profile

Loves to tackle challenges quickly and efficiently. Has an extensive and broad experience in the life science and pharmaceutical sector with eye for detail. Always looking for improvement to get the best possible results.

Experienced in QA and QC activities, including scientific report review, gap analysis of QMS and quality document writing and revision. Responsible Person activities, donor release and tissue establishment applications under European regulations for Human Tissue and Cell Products are part of her main focus.

Has in dept knowledge of clinical investigational products and clinical trial logistics and has experience as a (clinical) pharmacist for many years.

Specializations

• Human tissue regulations (e.g. HTA, Wvkl, EU Tissue Directives)
• RP (Responsible Person activities)
• Tissue establishment license applications
• Donor release
• ISO 13485
• Quality Assurance and Control
• Pharmaceutical and Medical Device logistics
• Investigational Medicinal Product
• Pharmacy/Pharmaceutical industry
• ICH-GCP

Certifications

• Responsible Person Human Tissue
• Internal Auditor: ISO 13485 (BSI)
• ICH-GCP (Profess)
• GMP and GDP