Quality Specialist & Deputy RP
We are seeking a Quality Specialist & Deputy RP to support our healthcare service provider client in Limerick, Ireland. This is a permanent role that requires travel to other sites in Ireland.
Key Responsibilities
* Sustain the Electronic Quality Management System across the business and assist the quality team in achieving Key Performance Indicator targets.
* Support the quality team in managing deviations and CAPAs, risk management, and change control.
* Act as Deputy Responsible Person for Wholesale Distribution Authorisations.
* Prepare for Regulatory and Client Audits.
* Collaborate on ISO certification processes for group entities.
* Integrate the Quality Management System into Business Units.
* Analyse data associated with the Quality System's performance (e.g. Management Reviews).
* Maintain Licenses, including Manufacturing licenses and Wholesale Distribution Authorisation.
* Train Business Units on quality and compliance matters.
* Report monthly metrics associated with the Quality Management System.
* Complete activities within required timelines.
* Highlight any issues around compliance proactively.
Requirements
* Degree in Life Sciences.
* Experience in Quality Assurance and Quality Management systems.
* Familiarity with GxP requirements and ISO 9001:2015 standards.
* Experience working as Deputy RP.
* Full driving licence.
Accountabilities
* Achieve KPI targets in collaboration with the quality team.
* Ensure compliance with regulatory requirements.
* Develop and implement effective quality systems.
* Maintain accurate records and reports.
* Promote a culture of quality and compliance within the organisation.