Reporting to the Site Director of Quality, the QA Analyst ensures that products manufactured, tested, released and distributed via Contract Manufacturing Organisations (CMOs) and contract laboratories comply with cGMP/GDP, Marketing Authorisations and Bimeda standards. The role leads QA oversight of external partners (CMOs/3PLs/contract labs), approves key quality documentation (e.g., deviations, change controls, CAPAs, validation), manages complaints and product quality reviews, and supports artwork control, stability, EM and recall readiness. The role also provides training and coaching on documentation and cGMP expectations and supports audits/inspections. CMO & Contract Partner Quality Oversight - Coordinate recurring CMO meetings and quality business reviews covering performance metrics, complaints, deviations, CAPAs, change controls and commitments. -Review/approve CMO Validation Protocols/Reports and Sampling Plans; ensure statistically justified approaches (e.g., ANSI/ASQ). -Lead/participate in CMO audits and Contract Lab Qualification; track and verify completion of CMO CAPAs and follow up actions. -Maintain Supply Chain Maps for CMOs and ensure GDP compliance across logistics partners; support qualification/oversight of 3PL and Contract Lab Testing. -Coordinate and approve QC Method Transfers to CMOs; ensure data integrity, comparability protocols, acceptance criteria and transfer reports. Quality Management System (QMS) Ownership -Maintain and update the Quality Manual/SMF; ensure alignment with licences and BAHL procedures. -Administer/approve Change Controls, Deviation/LIR, CAPA, Documentation Approvals, Documentation Reconciliation, and Archiving for CMO batches and records. -Plan and execute Internal Audits; collate outcomes into Management Review; track QMS KPIs and continuous improvement initiatives. - Oversee Calibration Programme from a QA standpoint and support QC Equipment Transfers lifecycle controls. - Issue, reconcile and archive Logbooks in accordance with data integrity expectations. Product Lifecycle & Technical Activities - QA review/approval of CMO Validation Protocol Approvals / Validation Report Approvals; ensure protocol to report traceability. - Establish and oversee Stability Programme Testing (protocols, pulls, investigations, reporting, commitments). - Administer EM Programme (Environmental Monitoring) data review/trending (as applicable for retained BAHL facilities or lab partners). Requirements • BSc in a science or related field. • Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry. • High integrity; excellent attention to detail; analytical thinker; organised; team oriented; self starter. • 2-3 years relevant experience in a regulated pharmaceutical environment (QA/QC) Desirable: • Experience with external manufacturing/CMO oversight and contract lab management. • Familiarity with HPRA, EU GMP/GDP, and product lifecycle documentation (SMF, PQR).