Quality and Compliance Specialist

Job description

Quality & Compliance Specialist Contract: Full-time, Permanent Location: Greenogue MAIN DUTIES & RESPONSIBILITIES Support maintenance of Wholesale Distribution Authorisation. Support the maintenance of the Electronic Quality Management System and support the quality team in achieving KPI targets. Maintain and update the Quality Management System (QMS) documentation relevant to global distribution. Author, review, and approve Standard Operating Procedures (SOPs) and Quality Agreements. Conduct quality assessments and audits of third-party logistics providers and CDOs. Support the quality-related onboarding of new partners. Investigate and lead quality deviation investigations. Lead and support CAPA and change control processes. Oversee temperature monitoring programs for cold chain and ambient shipments. Review and assess temperature excursion reports, ensuring appropriate impact and risk assessments and documentation. Support with the management of Quarantine and Recall requests. Oversee complaints and Pharmacovigilance events relating to global access supply. Assist in preparation for Regulatory Inspections and client audits and ensure readiness. Ensure audit findings are addressed and closed in a timely manner. Management of vendor, customer and product approvals. Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g., Management Reviews). Support monthly reporting of metrics associated with the Quality Management System. Accountable for completing activities within required timelines. Proactively highlight any issues around compliance. Willingly accepts challenging assignments. Demonstrates a strong interest in progressing towards the role of Deputy Responsible Person (RP). Work closely with Supply Chain, Regulatory, Program and Commercial teams to ensure seamless product access. QUALIFICATION, EXPERIENCE & SKILLS REQUIRED A third-level qualification in Pharmacy/ Science preferred Experience in medicines management, good distribution practice, or regulatory affairs Understanding of regulatory compliance in GDP, GMP, GCP, and GVP Experience of HPRA inspections Excellent PC skills, including Word & Excel PowerPoint etc. Strong analytical skills COMPETENCIES Process Improvement Mentality Self - Starter Demonstrates initiative Excellent Communication skills, both written and spoken Ability to learn and adapt quickly to changing priorities Attention to detail Team player Track record in generating high energy and engagement levels