Quality and Compliance Specialist

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