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 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 CAPAs, 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.
Skills: Risk Management QRM Site Quality Risk Register SQRR Compliance HPRA FDA