Quality Specialist & Deputy RP
We are seeking a Quality Specialist & Deputy RP to support our healthcare service provider in Limerick. As Quality Specialist & Deputy RP, you will play a key role in maintaining compliance with GxP requirements and ISO 9001:2015 standards.
Responsibilities
* Support the maintenance of our Electronic Quality Management System and contribute to achieving Key Performance Indicator (KPI) targets.
* Collaborate with the quality team to manage deviations and Corrective Actions, Pre-Approvals, and risk management, as well as change control processes.
* Assume the role of Deputy Responsible Person for Wholesale Distribution Authorizations.
* Assist in preparing for Regulatory and Client Audits.
* Aid in the process of obtaining ISO certification for group entities.
* Contribute to integrating the Quality Management System into Business Units.
* Analyze and compile data related to the performance of the Quality System, including Management Reviews.
* Maintain Licenses, including Manufacturing licenses and Wholesale Distribution Authorizations.
* Provide training to business units on quality and compliance matters.
* Prepare monthly reports on metrics associated with the Quality Management System.
* Meet deadlines and proactively highlight any issues related to compliance.
Requirements
* Bachelor's degree in Life Sciences.
* Experience in Quality Assurance and Quality Management systems.
* Knowledge of GxP requirements and ISO 9001:2015 standards.
* Previous experience as Deputy RP.
* Certification of a full driver's license.