Quality Specialist (Risk Management)

Quality Specialist (Risk Management)Department: Quality

Reporting to: Quality Systems Lead

Location: Cork

Vacancy: 1

Industry Requirement: Pharmaceutical background essential

Main Duties & ResponsibilitiesQuality 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.