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Regulatory Affairs Administrator 1

Req ID:  4365
Company:  DCC Vital - Fannin Ltd
Salary:  35000
Location: 

Kilcoole, IE Leopardstown, IE, Dublin 18

Contract Type:  Fixed Term Contract
Date Posted:  10-Aug-2022
Description: 

Medisource Ireland, HPRA licensed distributors of medicinal products, are leaders in the sourcing and supply of exempt medicinal products for supply within Ireland and internationally. Medisource are part of the wider DCC PLC Group, a FTSE 100 company.

 

 

Job title:                               Regulatory Affairs Administrator (Project support)

Location:                              Medisource – Kilcoole, Co. Wicklow

Reporting to:                       The Responsible Person/Quality Manager

Supervises:                          N/A

Liaises with:                        Medisource Quality, commercial and warehouse teams                                        

                                              3rd Parties including Regulatory Bodies, Service Providers, Customers &                                 Suppliers. Fannin Quality team.

 

 

The Opportunity:

Medisource Ireland Limited are recruiting for the part time position of Regulatory Affairs Administrator to join our Regulatory/Quality Team, supporting the activities required to ensure the continued compliant sourcing, storage and distribution of pharmaceutical products, in line with the principles of GDP & GMP. The Regulatory Affairs Administrator reports to the Responsible Person/Quality Manager and supports the Deputy Responsible Person and the Qualified Person in their roles. The contract will run for 9 months and has been designed to support the organisations transfer to a cloud-based Quality System.

 

Principal Duties and Responsibilities:

 

  • Support the continued compliant operation of the Medisource Quality System to ensure the application of GDP and GMP principles in the organisation
  • Support the transition of this Quality System away from a paper based to a cloud-based solution  
  • Participate in a broad range of administrative tasks that support the strategic objectives of the Quality/Regulatory Department and the transfer to a cloud-based Quality System.
  • Assist Quality Systems personnel in the drafting and review of the following types of documents: Standard Operating procedures, Process Deviations, Product Quality Defects, Pharmacovigilance reports, Root cause and CAPA analysis, Risk assessments & Change Controls and to take responsibility for their upload to the cloud.
  • Ensure that procedures are documented, understood, and followed.
  • Supporting the programme of self-inspection
  • Management and trending of data sets
  • Report writing
  • Maintenance of quality trackers
  • Prioritising tasks in response to the needs of the department and their customers
  • Adhoc tasks/projects as directed by the RP / as required by the role.

 

Experience & profile:

  • A Third Level Qualification is an advantage but not essential
  • Experience working to an established Quality Standard (e.g. ISO, GDP, GMP, MDR etc) 
  • Experience in a Quality Assurance/Regulatory role or similar
  • Experience within the Healthcare Industry an advantage
  • Strong IT skills
  • Exceptional attention to detail
  • Excellent communication skills, both oral and written
  • Demonstrate ability to manage workload effectively