Quality Specialist – GxP Compliance & QA (12-Month)

Uniphar; Leinster; Presencial; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

Uniphar is seeking a Quality Specialist for a 12-month fixed-term contract at Citywest/Greenogue to support good distribution activities and go-live of the Greenogue 2 facility. You will work with quality, operations, and commercial teams to ensure compliant processes and GxP standards across activities.

The role involves managing quality documentation, deviations, CAPAs, training, risk assessments, and regulatory reporting, with emphasis on audits and daily quality duties within a GMP-like

Qualificações

• A third-level qualification in science is preferred but not essential.
• A minimum of 3 years of experience in a GxP environment is preferred, by not essential.
• Experience in the operation of warehouse management systems.
• Excellent PC skills, including Word & Excel, PowerPoint, etc.
• Experience in technical writing.

Responsabilidades

• Assisting with the management of query tickets around returns and complaints.
• Monitoring the Temperature System (EMS) and printing weekly warehouse temperature reports for the RP/DRP review.
• Creation and Review of quality-related procedures and quality documentation within the Quality Management System.
• Assisting with the raising and investigation of Deviations and Non-Conformances within the Quality Management System.
• Support the business in the daily duties associated with rework activities.
• Assisting RP with documenting appropriate site-specific CAPAs and change controls.
• Assist with GDP and procedure-based training.
• Generation and review of risk assessments.
• Reporting of exempt medicines products to the HPRA.
• Supporting regulatory and supplier audits.
• Supporting the internal audit program.
• Completing temperature control checks for products at goods receipt.
• Investigate FMD alerts received by the site.
• Any other quality duties which may arise.

Conhecimentos

GxP experience

Technical writing

MS Office

Documentation

Formação académica

Science degree

Ferramentas

Warehouse management systems

Descrição da oferta de emprego

Uniphar is seeking a Quality Specialist for a 12-month fixed-term contract at Citywest/Greenogue to support good distribution activities and go-live of the Greenogue 2 facility. You will work with quality, operations, and commercial teams to ensure compliant processes and GxP standards across activities.

The role involves managing quality documentation, deviations, CAPAs, training, risk assessments, and regulatory reporting, with emphasis on audits and daily quality duties within a GMP-like