QA Operation SME

תיאור תפקיד

QA Operations SME
Location: Beit Shemesh – Vaccines Manufacturing Site

-Main Responsibilities
 Act as a QA subject matter expert, providing advanced guidance and support for routine and complex manufacturing operations
 Drive continuous improvement and optimization of quality processes in compliance with GMP requirements
 Prepare, review, and approve documents related to cross-functional manufacturing departments, including SOPs, protocols, validation documents, and reports
 Lead and support investigations, risk assessments, change controls, deviations, and CAPA (Corrective and Preventive Actions)
Provide QA oversight on-site or remotely for manufacturing activities
 Train and mentor QA and production staff on quality standards and regulatory requirements
 Review and approve batch manufacturing records
Prepare for and lead internal and external audits
 Support on-site and virtual inspections to ensure ongoing compliance with applicable regulations

-Education and Experience Requirements
 Bachelor’s degree or at least 5 years of experience in the pharmaceutical industry
 Extensive experience in manufacturing and/or quality processes within a GMP pharmaceutical environment
 Experience with EU inspections and project management – an advantage
 Additional experience in other quality areas – an advantage