Scientific Officer, Inspections – Compliance

Closing date for applications: 18/08/2019

ROLE SUMMARY

Reporting to the GMP Manager, the Scientific Officer (SO) will provide technical and organisational support to the teams responsible for licensing, registration and/or the inspection of:

 

  • Manufacturers of human and veterinary medicinal products
  • Manufacturers of active substances
  • Medical device manufacturers and authorised representatives
  • Notified bodies for medical devices
  • Wholesalers of human medicinal products
  • Clinical trial sponsors and investigator sites
  • Medicinal product brokers
  • Distributors and importers of active substances
  • Controlled drug economic operators
  • Scheduled substance economic operators
  • Medical device distributors
  • Cosmetic product manufacturers and distributors

 

The summary below represents a broad guideline for the role of the SO. Some aspects may be subject to change in accordance with business needs.

The Scientific Officer (SO) shall:

  • Liaise, as required, with the Licensing and Planning sections in relation to applications for authorisation of sites outlined above and in relation to applications to vary authorisations.
  • Assess new applications and variations received for manufacturer’s authorisations and wholesaler’s authorisations.
  • Enter authorisation details onto the HPRA’s database and will also issue GMP and GDP certificates
  • Assist inspectors in the preparation and follow up of inspections of the sites outlined above.
  • Assist in managing queries and will respond when it is appropriate to do so.
  • Assist in the review and follow up of reports regarding negative inspection outcomes that are forwarded to the HPRA e.g. Statements of Non-Compliance or warning letters issued by non-EU regulators.
  • Assist in the development and maintenance of the quality management system for licensing and inspection activities. This will include the preparation of quality system documentation.
  • Participate in the updating of GxP documents, inspections and licensing information on the HPRA website and the preparation and issuance of stakeholder guidance.
  • Be responsible for assisting in the coordinating training activities on GxP matters.
  • Also be required to assist in the preparation of responses to surveys on implementation activities when received from the stakeholders.

 

Applications should be submitted via the HPRA Recruitment Portal.


Role Profile    HPRA Recruitment Portal Application Form



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