About Quality Assurance Systems
We are committed to delivering innovative solutions that drive excellence in quality management.
Our vision is to create a culture of accountability, where every individual takes ownership of ensuring the highest standards of quality.
We achieve this by fostering a collaborative environment that promotes knowledge sharing, continuous learning, and improvement.
This enables us to develop and maintain robust quality management systems that meet or exceed regulatory requirements.
By doing so, we ensure that our products and services consistently meet customer expectations and needs.
The Opportunity
You will be responsible for supporting compliance with regulatory requirements, as well as the development and maintenance of the Quality Management System.
* Foster a culture of quality awareness across teams.
* Support site-wide compliance with regulations, including data integrity.
* Support readiness through timely and compliant progression of records.
* Provide real-time support for manufacturing, QC, and operations: including non-conformance management, root cause investigations, risk assessments, CAPA and effectiveness checks.
* Assist with internal/external audits and inspections.
* Support the complaints process, including investigation progression and final reports.
* Support supplier qualification process and related risk management.
* Review and approve documents for QA, ensuring compliance.
* Compilation of metrics.
* Support the Product Review process.
* Quality support for major projects, including LEAN/OPEX activities.
* Other support areas include but are not limited to: quality investigations, authoring, training of new personnel and batch review activity, as assigned.
Essential Knowledge & Experience
* Exceptional attention to detail and organizational skills.
* Proficiency in Microsoft Office Suite, including MS Excel.
* Excellent communication and collaboration skills.
* Ability to manage multiple tasks and deadlines effectively.
Education/Qualifications
* Third level qualification in Science discipline or equivalent.