Senior Quality Assurance Specialist

Senior Quality Assurance Specialist(hybrid) RK3368 Contract - 12 months Cork Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties : Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements. Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates. QA Review and Approval of SOPs, Work Instructions and forms from other departments. Attendance at Daily / Weekly Operations led Team Meetings. Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective. QA review and approval of Warehouse Shipping Picklist. Primary QA point of contact for Quarantine Shipments. Responsible for Batch Book Filing & Archival. QA review and approval of quality non-conformance (NC) records and customer complaint 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. Experience and Education : Third level Degree in a science or pharmaceutical discipline. A minimum of 3 years of experience within the Pharmaceutical Industry. A working knowledge of quality processes and systems is desirable. Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. If interested in this posting please feel free to contact Rachel Kent on or for further information.