Quality Specialist (Risk Management)
Department:
Quality
Reporting to:
Quality Systems Lead
Location:
Cork
Vacancy:
1
Industry Requirement:
Pharmaceutical background essential
Main Duties & Responsibilities
Quality Risk Management
* Execute the Quality Risk Management (QRM) and Site Quality Risk Register (SQRR) processes.
* Maintain effective governance, communication, and management systems.
Audit & Inspection Readiness
* Support preparation and management of internal and external audits/inspections.
* Follow up on audit actions, CAPAs, and Quality approval of non-conformance (NC) records.
Risk & Improvement Activities
* Participate in site risk assessments.
* Execute site and quality-driven improvement projects aligned to the Risk Register, including but not limited to:
* Supplier Qualification
* Reclassification of plant areas
* Site Data Integrity Program
Project Management
* Manage projects to meet strict timelines and achieve established milestones.
* Provide regular progress updates to Quality and Site Leadership Teams.
Quality Systems Responsibilities
* Perform Quality review and approval of SOPs, Work Instructions, and forms (including periodic reviews).
* Conduct Gemba walkdowns and Inspection Readiness walkdowns from a Quality perspective.
* Review and approve NC records and participate in Root Cause Analysis meetings.
* Initiate and own Quality non-conformance records.
* Serve as Quality assessor, reviewer, and approver for NC records.
Key Experience Required
* Demonstrated experience with
data integrity
as a QA Specialist.
* Proven experience in
risk management projects
and driving continuous improvements.
Key Skills & Competencies
* Builds strong, productive relationships.
* Collaborates effectively with teams and individuals.
* Actively seeks opportunities for professional growth.
* Applies best practices to improve business operations.
* Maintains accountability for compliant and flawless execution.
* Makes decisions that deliver customer value.
* Demonstrates adaptability and effective change management.
* Always acts with integrity and aligns with the Credo.
Education & Experience Requirements
* Third-level degree in a scientific or pharmaceutical discipline.
* 3–5 years' experience
in a quality or compliance role within the biological and/or pharmaceutical industry.
* Solid understanding of regulatory requirements including FDA, HPRA, EMEA, and other relevant authorities.