QA Specialist

2 weeks ago


Cork, Ireland Claran Consultants Ltd Full time

QA Specialist role - initially a 12 month contract ROLE: -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. REQUIREMENTS: Education and Experience: -Third level Degree in a science or pharmaceutical discipline. -A minimum of 3 years of experience within the Pharmaceutical Industry. Experience in sterile or aseptic environment - min 3 years -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. Skills: Pharmaceutical Batch Review QA



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