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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Specialist & Deputy RP


Reference:SC201241 Location: Limerick
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Engineer, QA Executive, QA Manager, QA Specialist, Quality Assurance Officer, Quality Assurance Technologist, Quality Manager, Quality Specialist

Quality Specialist & Deputy RP
Our client, a healthcare service provider, are currently recruiting for a Quality Specialist & Deputy RP to join their team on a permanent basis. As Quality Specialist & Deputy RP you will support the businesses QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirement and ISO 9001 2015 requirements . This role is based in Limerick with travel to other sites in Ireland so a full drivers licence is required.

Responsibilities

  • Support the maintenance of the Electronic Quality Management System across the businesses and support the quality team in achieving KPI targets
  • Support the quality team in the management of deviations and CAPAs, risk management, and change control
  • Support as Deputy Responsible Person for the required Wholesale distribution authorisations
  • Assist in preparation for Regulatory and Client Audits
  • Assist with ISO certification process for the group entities
  • Assist with the integration of QMS into Business Units
  • Assist with the compilation and analysis of data associated with the performance of the QualitySystem (e.g. Management Reviews)
  • Support maintenance of Licenses including Manufacturing licenses and WholesaleDistribution Authorisation
  • Assist with the training of business units on quality and compliance matters
  • Support monthly reporting of metrics associated with the Quality Management System
  • Accountable for completing activities within required timelines
  • Proactively highlight any issues around compliance
  • Happy to engage in challenging assignments
Requirements
  • Degree in Life Sciences
  • Experience in Quality Assurance and Quality Management systems
  • Experienced with GxP requirements and ISO 9001 2015 requirements
  • Experience working as Deputy RP
  • Full drivers licence
For more information please contact Sinéad Cullen on +353879500821 or [email protected]