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Quality Specialist
1 month ago
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 Quality System (e.g. Management Reviews)
- Support 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
- 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
