QA/QP Lead

To strengthen our Commercial Affiliate in Ra’anana, Israel we are currently hiring a

Quality Assurance and Qualified Person Lead (m/f/x)

(fulltime/ permanent)

The Opportunity

You will perform all activities as Qualified Person and Quality Manager for the Israeli affiliate of CSL Behring, which is in an establishment phase.

You will implement and maintain the QMS of CSL Behring Israel.

Main Responsibilities And Accountabilities

• Release/ rejection / partial rejection of lots to the Israeli market according to MOH regulations, GMP and GDP requirements
• Supervise the rework/repackaging of products
• Handle returns and recalls
• Prepare and lead MOH audits, assistance and participation in quality audits, either internal or external
• Create and update SOPs
• Conduct GMP and GDP trainings
• Condut supplier audits and qualification
• Prepare and present periodic Quality Management Reviews
  
  

• Licensed Pharmacist
• 3+ years’ experience in the pharmaceutical industry and Medicinal Products importation, as well as in GDP and GMP
• Previous experience as Qualified Person
• Preferably knowledge in pharmacovigilance
• Ability to perform and maneuver in a global, highly matrixed environment
• Collaborative mindset
• Fluent in Hebrew and English