QA Specialist (Senior)

Senior QA Specialist position at a Global Pharmaceutical company based in Little Island, Cork, IRL, responsible for various QA-related tasks and activities.

Requirements

• Batch Record Review and material release
• Quality review and approval of Master Batch Record
• QA Review and Approval of SOPs, Work Instructions and forms
• Gemba Walkdowns & Inspection Readiness Walkdowns
• QA review and approval of Warehouse Shipping Picklist
• Primary QA point of contact for Quarantine Shipments
• Batch Book Filing & Archival
• QA review and approval of quality non-conformance records
• Initiation and ownership of QA non-conformance records
• Responsible for periodic review of Quality Assurance and Quality Systems SOPs
• Primary Quality point of contact for attendance at Root Cause Analysis meetings
• Primary QA point of contact for the Returns process