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Details

Graduate Quality & Regulatory Affairs Coordinator


Reference:AGYK-216646 Location: Dublin
Qualification:DegreeExperience:Graduate
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Graduate


Graduate Quality & Regulatory Affairs Coordinator

This is an excellent opportunity to be working with a dynamic Medical Device company based in Dublin. The successful candidate will be working closely with QA/RA Director and will have a chance to work with all the cross functional teams in the organization . This is an fantastic opportunity to understand and learn the Manufacturing, Quality and Regulatory aspects of Medical device company.

Role:

The primary purpose of the role is to manage the ongoing maintenance of the compliance requirements ensuring they meet and exceed all contractual and regulatory obligations, providing best practice.
·Support the Quality Manager in relation to the maintenance of ISO Quality Management System
·Assist in carrying out of Internal Audits to ISO 9001:2015 standard
·Issue and Track non-conformances and CAPAs
·Document Control – version control for SOPs, index register, go live and communication
·Monthly checks for quarantine, calibration and temperature monitoring
·Product Risk assessments
·GDPR: Ongoing administration of Data Protection requirements
·Labour Standards: Preparation of required documentation prior to audit
·Responsible for the introduction of new /amended SOPs into QMS working closely with the Projects Department
·Improving systems and processes through Continuous Improvement Methodology

Experience:

·Third Level Qualification / Degree
·1+ Years Quality, Compliance, RA Experience in the Pharmaceutical or Medical Device Sector



If you would like further Information you can contact the recruiter directly:



Jannet Diana | Tel: +353 (0) 1 507 9255