QA referent

 1. 1. Supporting both Israeli and abroad, internal and external customers
2. Writing, reviewing and training working documents (SOPs, CAPA, Deviations, material specifications, etc.)
3. Writing, reviewing and approval of risk assessment, including mitigations and controls 
4. Raw materials and consumables transformation to GMP (raw materials and consumables compliance)
5. Supplier evaluation and qualification
6. Helping in QMS establishment and maintaining, transformation of protocols to batch record
7. Providing support in GMP issues
8. Material approval and release from warehouse
9. Working in a dynamic and ever-changing environment
10. The role may include domestic travelling 
 
Requirements: 
• Excellent Hebrew & English – written & spoken 
• Well organized
• Quick learner
• Ability to adjust to quick changes
• Proven good communication and personal skills
• Open-minded and flexible thinking
• Relevant degree (Quality, Biology, Biotechnology etc.)
• At least 1-year experience in a GMP environment 
• Experience in writing risk assessment for cleanrooms
• Experience in raw materials and consumables evaluation and transformation from development to clinical phase
• Background in cell culture or aseptic manufacturing- a plus