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