Overview
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
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Quality Specialist • Limerick, Ireland