Quality Assurance Manager
Coordinate QA resources across functional areas to achieve business objectives, ensuring the Quality Management System (QMS) is effective and compliant.
Key Responsibilities:
* Oversee QMS implementation and maintenance, approving SOPs and quality documents as necessary.
* Represent the company during HPRA inspections, facilitating effective communication and resolving queries.
* Support HPRA inspections, assisting in the preparation of written responses and ensuring timely resolution of findings.
* Prepare and approve HPRA variations, ensuring compliance with regulatory requirements.
* Provide QA expertise and manage quality issues through to closure, ensuring minimal disruption to operations.
* Conduct internal audits to ensure operational compliance, identifying areas for improvement.
* Lead the review and approval process for Non-Conformances (NC), Corrective Action Preventative Actions (CAPA), change controls, and complaints.
* Organize annual reviews of suppliers and ensure regular updates to technical agreements with licensees and third-party contractors.
* Implement the Self Inspection/Internal Quality Audit program, promoting a culture of continuous improvement.
* Oversee the reporting and investigation of non-conformances, identifying CAPAs to drive quality improvements.
* Elevate issues to senior management as required, maintaining open communication channels.
* Collaborate with cross-functional teams as the quality representative, providing guidance on quality and regulatory matters to other departments.
Requirements:
* Hold a Bachelor of Science (Honours) degree or equivalent in a relevant field.
* 1 year of experience in a similar role, with a strong understanding of quality and regulatory frameworks.
* Work authorization: Ireland.
* Location: In-person (ideally).