QA SpecialistSenior QA experience particularly in Batch Release, Distribution/Warehouse, Review/submission of Technical paperwork, Annexe 21.Manage and Maintain the Quality Management System (QMS) ensuring it is fit for purpose under EU GMP and GDP regulationsApprove SOPs and Quality System Documentation to support QP release of DP under EU importationPrepare, Update & Review Technical Agreements with partners and third partiesSupport HPRA inspections and prepare written responsesOversee Quality aspects of new product introductionReview and approve non- conformances, CAPAs, Change Controls and ComplaintsManage Supplier and Customer GDP compliance reviewsEnsure GMP- compliant batch record packs for releaseConduct Internal Audits and Management ReviewsLead the implementation of continuous improvement initiatives within Quality operationsKnowledge:Must be familiar with EMA & FDA regulations; ICH and WHO guidelines - Preferable knowledge of CMC stage gates and submission types.Understand European and Rest of world regulatory requirements, guidelines, and expectations.Be up to date with respect to the current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).Demonstrated knowledge of Quality Management System and continuous/process improvement tools.The person will report into our Senior QP and will not have any direct reports.