GMP Inspector, Inspections section - Compliance

Closing date for applications: 25/08/2019

 
Reporting to a Senior Inspector, the Inspector will be primarily responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP).

 

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 Community Directives, Regulations and Guidance.  These sites may include;

 

  • Manufacturers and distributors of medicinal products.
  • Manufacturers of investigational medicinal products.
  • Sites involved in the storage of medicinal products.
  • Manufacturers of active pharmaceutical ingredients and certain excipients.
  • Quality control laboratories.

 

The role involves inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has sought or for which it is already authorised.

 

The Inspector provides technical information and advice to relevant individuals and organisations both internal and external to the HPRA.

 

The Inspector provides support to the enforcement and execution of national regulations in relation to medicinal products.

Applications should be submitted via the HPRA Recruitment Portal.


Role Profile                                 HPRA Recruitment portal Application Form



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