Are you a QA Specialist with at 3 years API, Sterile/Aseptic manufacturing experience?There is a super contract opportunity available in Cork with a well known Pharmaceutical API company for an initial 12 months - possible to extend beyond this.Apply today Tel Role:Batch Record Review and material release (includingCoA) 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 departmentsAttendance at Daily/Weekly Operations led Team MeetingsResponsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspectiveQA 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.Education and Experience: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.