Quality Specialist

2 days ago


Limerick, Ireland Life Science Recruitment Full time

Quality Specialist & Deputy RP
Our client, a healthcare service provider, is 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 business's 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 driver's license is required.

Responsibilities

- Support the maintenance of the Electronic Quality Management System across the businesses and assist the quality team in achieving KPI targets.
- Support the quality team in the management of deviations and CAPAs, risk management, and change control.
- Act as Deputy Responsible Person for the required Wholesale Distribution Authorisations.
- Assist in preparation for Regulatory and Client Audits.
- Assist with the ISO certification process for the group entities.
- Assist with the integration of QMS into Business Units.
- Compile and analyze data associated with the performance of the Quality System (e.g. Management Reviews).
- Support the maintenance of Licenses including Manufacturing licenses and Wholesale Distribution 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.
- Engage in challenging assignments.

Requirements

- Degree in Life Sciences.
- Experience in Quality Assurance and Quality Management systems.
- Familiarity with GxP requirements and ISO 9001:2015 requirements.
- Experience working as Deputy RP.
- Full driver's license.

For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie

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