Job DescriptionA 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.ROLEBatch 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 andforms from other departments.Attendance at Daily/Weekly Operations led TeamMeetings.Responsible for Gemba Walkdowns & InspectionReadiness 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-conformancerecords.Initiation and ownership of QA non-conformancerecords.Responsible for periodic review of Quality Assuranceand Quality Systems SOPs.Primary Quality point of contact for attendance at RootCause Analysis meetings.Primary QA point of contact for the Returns process.Job RequirementsThird level Degree in a science or pharmaceuticaldiscipline.3+ years of experience within the Pharmaceutical Industry.A working knowledge of quality processes and systemsis desirable.Demonstrated knowledge and application of industryregulations 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.