Pharma Quality consulting services
About Dr. Gil Zomber
Gil Zomber, Ph.D. is a freelance consultant and a seasoned pharmaceutical professional who has been responsible for biological products,
(R&D and commercial stages), managing Contract Manufacturing Organizations (CMO) and supporting client and CMO sites in preparation for and during FDA inspections. He has extensive knowledge of biotechnological processes and analytics of biologics, is widely experienced in supplier audits, including API manufacturers (biologics and small molecules), excipients, primary packaging, contract laboratories, and more. Additionally, he is experienced in biosimilars development programs and has led global investigations of major deviations. His experience includes biologics and parenteral products.
Services
- Quality Systems including documentation systems, training, change control, record review, raw material, intermediate and finished product testing, supplier qualification, deviations and CAPA.
- Internal and external audits and mock inspections of biological products (R&D and commercial stages).
- GMP audits of Contract Manufacturing Organizations (CMOs); deliver support in preparation for and during FDA inspections
- Biosimilars development programs
- Biotechnological processes and analytics of biologics
- GMP supplier audits, including API manufacturers (biologics and small molecules), excipients, primary packaging, contract laboratories
- Quality Due Diligence reviews
- GMP training and other quality issues training (Data integrity, SPC, CPV ..)
Dr. Gil Zomber Professional Experience
- Senior Associate in the Compliance Practice at Lachman Consultants
- Lecturer in BioMed MBA, Hebrew University in Jerusalem.
- Founder of Gil Pharma.
Push the quality upward
In the past:
- Senior Associate in the Compliance Practice at Lachman Consultants
- Lecturer in BioMed MBA, Hebrew University in Jerusalem.
- Vice President, Quality – Ayanapharma (Israel)
- Teva (Israel), Senior Director, Quality Assurance, R&D Biologics
- Israel Institute for Biological Research (Israel), Quality Assurance Manager of GMP Pharmaceutical Project
- Life Science Research (Israel), Team Leader, Pharmacological / Toxicological Biochemical Projects
Our Clients
