Flexible Working
Learning & Development
Wellbeing

Scientific Officer - Inspections (GMP), Compliance / Oifigeach Eolaíochta - Cigireachtaí (GMP), Comhlíonadh

Salary €44,831-€74,404 per annum (incremental scale)
Location Hybrid
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This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.

The Vacancy

Reporting to the Good Manufacturing Practice (GMP) Operations Manager, the Scientific Officer (SO) will provide technical and organisational support to the teams responsible for quality defect investigations and licensing, registration and the inspection of:

  • Manufacturers and importers of human and veterinary medicinal products
  • Manufacturers of active substances
  • Clinical trial sponsors and investigator sites
  • Medicinal product brokers

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) will:

  • Manage applications for pre-submission meetings for manufacturer’s/importer’s authorisations (MIAs).
  • Assess new applications and variations received for manufacturer’s authorisations, and active substance registrations.
  • Enter authorisation details onto the HPRA’s database and issue GMP certificates. 
  • Track data that supports reporting on key performance indicators as required.
  • Liaise, with the other sections in relation to applications to vary MIAs.
  • Assist in coordinating actions in relation to cases under Compliance Management.
  • Assist in managing queries and will respond when it is appropriate to do so.
  • Assist in the review and follow up actions required in relation to reports regarding unfavourable inspection outcomes that are forwarded to the HPRA e.g. Statements of Non-Compliance or warning letters or official action indicated (OAI) notifications issued by non-EU regulators.
  • Coordinate requests from mutual recognition agreement partners for inspection report requests.
  • Assist in the development and maintenance of the quality management system for licensing and inspection activities, including 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 coordination of training activities on GxP matters.
  • Assist in the preparation of responses to surveys on implementation activities when received from the stakeholders.

The Company

We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.

Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

The Benefits

Flexible
working

Learning & Development

Wellbeing

Employee Assistance Programme

Beneficial Leave Policies

Pension Scheme

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Published

Not Published

Closing

in X days

{Expiry}