
Quality Specialist
- Ireland
- Contract
- Full-time
- Assisting with the management of query tickets around returns and complaints.
- Monitoring the Temperature System (EMS) and printing weekly warehouse temperature reports for the RP/DRP review.
- Creation and Review of quality-related procedures and quality documentation within the Quality Management System.
- Assisting with the raising and investigation of Deviations and Non-Conformances within the Quality Management System.
- Review and Approval of Customer and Vendor Setups
- Review and approval of new product set-ups.
- Assisting with carrying out annual Bona Fides checks.
- Administration and support of Recalls/Quarantine Requests.
- Support the business in the daily duties associated with rework activities.
- Assisting RP with documenting appropriate site-specific CAPAs and change controls.
- Assisting the RP with close-out of deviations.
- Assist with GDP and procedure-based training.
- Generation and review of risk assessments.
- Reporting of exempt medicines products to the HPRA.
- Coordinating product quality complaints.
- Supporting regulatory and supplier audits.
- Supporting the internal audit program.
- Completing temperature control checks for products at goods receipt.
- Investigate FMD alerts received by the site.
- Any other quality duties which may arise.
- A third-level qualification in science is preferred but not essential.
- A minimum of 2 years of experience in a GxP environment is preferred, by not essential.
- Experience in the operation of warehouse management systems.
- Excellent PC skills, including Word & Excel, PowerPoint, etc.
- Previous experience in administrative duties is an advantage