A Senior QA Specialist is required by CareerWise Recruitment to join our based Cork based pharma manufacturing client - Need experience in sterile or aseptic environment. 12-month initial contract role. 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: * Third level Degree in a science or pharmaceutical discipline. * 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, Please call Diarmuid Buckley today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: QA Specialist pharmaceuticals