QA Specialist

About the role

The ESO Quality QA Specialist is responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and suppliers. The role ensures compliance with applicable Quality Management System, GMP, GDP and regulatory requirements and supports audits, product lifecycle activities and quality decision-making.

What you'll do

• Responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and…
• Conduct Root Cause Analysis and follow up agreed corrective and preventive actions
• Review and assess change controls and their Quality impact
• Review GMP manufacturing documentation, analytical data, CoAs/CoCs and relevant batch documentation
• Support batch release decisions through review of Quality documentation

What you need

• 5–9 yrs of experience
• GMP
• Root cause analysis
• Safety management
• Internal audit
• ISO 9001
• Pharmacovigilance
• Any graduate

Good to have

• Chemistry
• Biology