Our client, a leading global Pharma and Medical Devices organisation based in Dublin West, is seeking an experienced QA Specialist to join the Quality team. This is a brand new role due to company expansion.

The QA Specialist will have responsibility for the maintenance of the Quality Management System on site and Global External Manufacturing Quality Systems.

The Role

Duties and responsibilities of the QA Specialist will include:

• Quality activities related to the maintenance of the conditions of the following authorisations:
  • Manufacturing Importation Authorisation (MIA), batch release
  • Wholesale Distribution Authorisation (WDA)
  • ASR Active Substance Registration
  • Marketing Authorisation
• Implementing Inter Company Agreements between the company and global partners
• Preparing QA documents as required for the implementation of the QMS including change controls, Quality Manual, SOPs, forms, Quality Agreements
• Preparing applications (variations) for changes to authorisations held by the company
• Keeping up to date on current Good Distribution Practice and Good Manufacturing Practice
• Control of quality documents, drafting, issue and withdrawal of quality documents
• Administrative communications with HPRA, EMOs and affiliates
• Escalation of issues to Quality Director as appropriate

The Person

You will have skills and experience in the following:

• BSc in Science or equivalent
• 3+ years' experience working in Quality Assurance in the pharmaceutical or medical device industries
• Thorough working knowledge of GxP's and regulatory expectations for medicinal products and medical devices
• Ability to work on their own initiative and within teams
• Will have successfully led a project to completion
• Excellent ability to deliver results, with strong interpersonal and influencing skills
• Strong communication and organizational skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.