Closing date for applications: 02/10/2019
Role Summary
Reporting to the Blood, Tissues & Organs (BTO) Manager, the Inspector will be primarily responsible for assessing the compliance of blood establishments, tissue establishments, organ procurement centres and organ transplant centres, with the requirements of European and National legislation and associated good practice guidelines.
The content below represents a broad guideline for the role of Inspector. Some aspects may be subject to change in accordance with business needs.
The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation (in Ireland), European Directives, Regulations and relevant guidance. These sites may include:
- Blood Establishments
- Tissue Establishments
- Organ Procurement Centres
- Organ Transplantation Centres
- Manufacturers of advanced therapy medicinal products
- Other sites regulated by the Health Products Regulatory Authority (HPRA)
The role involves inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has sought authorisation or is already authorised for. The standards that apply include:
- Good Practice guidance for tissues and cells, including relevant European Commission and Council of Europe guidance.
- Good Practice guidance for blood and blood components, including relevant European Commission and Council of Europe guidance.
- National and European guidelines in relation to organ procurement and transplantation.
- Good Manufacturing Practice (GMP); Good Distribution Practice (GDP); Good Laboratory Practice.
The Inspector will provide technical information and advice to relevant individuals and organisations both internal and external to the HPRA.
The Inspector will provide support to the development and execution of national regulations in relation to, blood, tissues and cells and organs.
The Inspector will participate in the review and assessment of annual reports received from stakeholders.
The inspector will interact and provide relevant input into the continued development of systems relevant to the Inspections section
Applications should be submitted via the HPRA Recruitment Portal.
Role Profile HPRA Recruitment Portal Application Form