Our client, a leading global healthcare company based in Sligo, is seeking to hire a Quality Specialist on an initial twelve-month contract.
Responsibilities of a Quality Specialist (Full job description available on request):
Coordinates quality decisions from a CAPA perspective at the site and ensures compliance with all aspects as applicable.
Work in conjunction with relevant Document/ Process owners to identify and organize CFTs.
Initiates site change plan and document change request activities (as required) for changes identified through product / process improvement, transfer activities and/or identified compliance issues.
Acts as a SME for the CAPA system, involved in Process community and site meetings.
Co-ordinate and manage change plan and document change requests through to closure, including tracking of identified deliverables and action items.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Participates in the development or modification of risk management files.
Assist initiators of change control documentation, including change plans, design plans and change requests (as required) to aid in the implementation of change.
Reviews and approves changes to QSR and DMR documentation as required.
Acts as a SME for the CAPA system, involved in Process community and site meetings.
Ideal background:
Third Level Qualification in a relevant discipline OR relevant combination of education or experience.
At least 3 years work experience in Quality or related field experience; less experience may be appropriate with advanced degree.
Demonstrates technical and business competencies that drive results and continuous improvement
Excellent communication, team and organizational skills required.
For a confidential discussion and more information on this Quality Specialist role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060