Description: 1x Vacancy Max FBR of 55 They need experience with data integrity as a QA Specialist and this must be demonstrated in the application. They also need experience with risk management projects and driving improvements. Need pharma background Position Title: Quality Specialist (Risk Management) Department: Quality Report to: Quality Systems Lead Location: Janssen, Little Island Diversity, Equality & Inclusion: For more than 130 years, Diversity, Equity & Inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Ireland are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means You Belong ! Janssen Pharmaceuticals Sciences UC, operating in Little Island, Cork since 1981, is dedicated to manufacturing bulk Active Pharmaceutical Ingredients (APIs) distributed globally. Join our team of hardworking individuals who share a passion for making a difference in an environment that empowers you to drive your career. Position Summary: The position will be located at the Little Island site and will be part of the Quality Team. This position is responsible for Quality Risk Management and Quality Systems compliance activities related to Janssen Pharmaceutical Sciences (JPS) UC as required by Good Manufacturing Practice (GMP). Main duties and responsibilities: The key elements of the role can be broken down into the following clusters: Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained. Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPA s, and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to, Supplier Qualifications. Reclassification of plant areas. Site Data Integrity Program Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams. Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews. Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective. Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings. Initiation and ownership of Quality non-conformance records. Quality assessor, reviewer and approval of quality non-conformance (NC) records. Key Skills and Competencies required: Builds strong productive relationships. Demonstrates ability to work with teams and individuals. Seeks opportunities to grow and develop professionally. Uses best practices to improve business operations. Holds self-accountable for compliant and flawless execution. Takes personal responsibility for decisions that successfully build customer value. Effectively manages and adapts to change. Always demonstrate Integrity and Credo-based actions. Education and Experience: Third level Degree in a science or pharmaceutical discipline. A minimum of 3 to 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. Enable Skills-Based Hiring No Actual End Date try { var fgTooltip = new FG.Tooltip({ element: $('cf_descz20042714312056838244905'), text: "Enter\x20actual\x20intended\x20end\x20date" }).initialize(); } catch(err) {} Additional Details Pool : (No Value) Actual End Date : 2026-11-29 Job Function : Quality Job Subfunction : Quality Assurance Equivalent Permanent Annual Salary : 0.00