Experience

Entera Bio Ltd.

• Biotechnology
• 1 - 100 Employee

• Quality Assurance Specialist

  • Jun 2023 - Present



Gamida Cell Ltd.

• United States
• Biotechnology Research
• 1 - 100 Employee

• QA Associate, Vendor management and Supply chain

  • Jun 2021 - Jun 2023

  • Establishment and implementation of vendor qualification system following a gap analysis process and mitigation • Supplier and raw material quality assessments and qualification program • Supplier Quality Audits • Quality Agreements • Establishment of a supply chain system following a gap analysis process and mitigation • Review, prepare and update Standard Operating Procedures (SOPs) • QA release of raw materials • Ensure GMP compliance of Supply Chain activities to support global IND, CTA, BLA and MAA submissions, PAI inspections, and commercial manufacturing activities with regard to: • Support in Regulatory submissions to FDA and reply to Deficiency letters • Assist in the preparation of, and host regulatory agency inspections (FDA, MOH, etc.). • Internal audits • QMS (CAPA, Change control, Risk assessment, Deviations) • Issuance/approve labels for clinical batches • Oversee Clinical product manufacturing, storage and shipment Show less



Rafa Laboratories

• Israel
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Quality Assurance Specialist

  • Feb 2016 - Jun 2021

  Raw material coordinator. Experience in: • Suppliers qualification • Contract giver qualification • Quality agreements • Review, prepare and update Standard Operating Procedures (SOPs) • Support in Regulatory submissions to the health authorities and reply to the Deficiency letters • Participation in regulatory audits (ISO, MOH, FDA) • Internal audits • Suppliers audits • QMS (CAPA, Change control, Risk assessment, Deviations) • Trainings Raw material coordinator. Experience in: • Suppliers qualification • Contract giver qualification • Quality agreements • Review, prepare and update Standard Operating Procedures (SOPs) • Support in Regulatory submissions to the health authorities and reply to the Deficiency letters • Participation in regulatory audits (ISO, MOH, FDA) • Internal audits • Suppliers audits • QMS (CAPA, Change control, Risk assessment, Deviations) • Trainings



Dexcel Pharma

• Israel
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Analytical researcher & Project coordinator

  • Aug 2010 - Apr 2015

  Development of analytical methods. Development of analytical methods.