- Location
- Greenogue - Office, Ireland
- Type
- Full-time
- Department
- Legal
- Source
- Workday
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
Skills
GCPExcelGMPCompliance