Job Title: Aseptic Quality Assurance Specialist Description We are seeking an experienced Aseptic Quality Assurance Specialist to join our team in Dublin. As a key member of our quality department, you will be responsible for ensuring compliance with regulatory requirements and industry standards. 1. Act as a representative for the Quality team in the absence of the quality supervisor/manager 2. Daily briefing on Quality batch review/approval 3. Provide quality performance information as required 4. Evaluate qualification plans, sampling plans for water systems, raw materials, environmental monitoring, in-process and FP testing assist and participate in qualification processes such as cleaning processes clean rooms sterilisation processes aseptic gowning other qualification areas where necessary Review approval of qualification pack Qualify grouning entry Grade A/B area Support process simulation batch manufacture activities including observation critical interventions batch review review Batch Records Lead/participate technical deviations investigations CAPA change controls provide support manufacturing area Maintain high level technical writing expertise stay current regulatory trends Involve customer complaint investigation if needed reviews SOP's validation protocols reports GMP documentation internal audits continuous improvement initiatives regulatory requirements product monitoring Perform spot check/walk-through areas Support annual product Reviews back room during external audit inspections Represent Team project management Process/product/system projects Participate risk management provides expert tech skills Albumin Manufacturing Area BSc Degree at least 3 years experience QA production function pharmaceutical devices companies Strong tech writing Competence MS Word Excel PowerPoint Good organizational Flexibility Results oriented Ability make decisions handle multiple deadlines What we offer competitive salary pension scheme contribution rates company match Medical Insurance ongoing career opportunities rapidly work environment succession planning promotions wellness social events Health Wellness Social Activities#F-Welcom]