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.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel