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Quality Specialist

3 weeks ago

Limerick, Limerick, Ireland Life Science Recruitment Full time

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.