QA Specialist

תיאור תפקיד

 QA Specialist – Supplier & Materials Qualification 
Responsible for managing supplier qualification, approval, and ongoing oversight of suppliers, service providers, and incoming materials, in compliance with GMP requirements and internal quality systems.
Key Responsibilities:

Manage qualification, approval, and periodic requalification of suppliers and service providers
Establish, review, and maintain Quality and Technical Agreements
Plan and execute the annual Supplier Audit Program, including follow‑up of findings and CAPAs
Monitor, trend, and evaluate supplier performance (quality, complaints, deviations, on‑time delivery)
Maintain and periodically review the Approved Suppliers List (ASL)
Oversee QA release of incoming raw and packaging materials, including review of CoAs, specifications, and trending of critical quality parameters
Lead supplier‑related complaints, investigations, root cause analysis, and CAPA management
Support regulatory inspections and GMP audits related to supplier qualification and material control

Requirements:

Bachelor’s degree in Life Sciences or a related scientific field
Minimum 5 years of QA experience in a GMP‑regulated environment, with hands‑on involvement in supplier qualification and material management
Proven experience with supplier audits, Quality/Technical Agreements, and QA release of incoming materials
Strong knowledge of GMP requirements related to suppliers and materials
High attention to detail, strong organizational skills, and ability to manage multiple interfaces
Excellent communication skills and ability to work effectively with suppliers and internal stakeholders
Proficiency in Microsoft Office
Excellent written and verbal communication skills in English and Hebrew

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