Responsibilities of the role: The successful candidate will be responsible for coordinating all QA duties relating to QP batch release and communicate all issues relating to batch release schedule in a timely manner to schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines. To proactively identify and implement industry best practices including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance. Responsible for coordination of the certification of finished product batches to the market as required under the EU Directive 2001/83/EC. Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization. Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff. Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required. Pro actively participate in the QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required. Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective. Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract labs. Coordinate and provide QP support to QA colleagues with product quality / license impact assessment for deviations. Ensure Quality Managers are appraised on all Quality related issues. Education and Experience required: • 3rd level qualification in Science / Engineering discipline. • Industry experience as a QP and eligibility to act as a Qualified Person in line with local and EU directives. • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. If you are interested in this position, please forward your CV to email@example.com or call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.
103 days ago