QA Production Manager

Harry Walsh Associates Ltd

Cork

Reporting to the Director of Quality Operations, and leading a team of 12, The QA Manager (Production) is responsible for managing and providing leadership to the QA Production team of QP’s, QA Specialists and QA analysts, as well as liaising closely with the Production Manager in the Cork Site to deliver the customer and business needs in a compliant manner that enhances the direct relationship culture. The QA Manager (Production) will engage with the relevant support departments and build strong relationships with same. Duties: • 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 lead the Production 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 support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business. • As part of the QA Management Team responsible for driving the Quality goals in support of the overall business objectives. • Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice. Experience: 8years + QA experience within a Pharma manufacturing environment. Must have sterile manufacturing experience. Degree in Science/ engineering discipline. Previous people management experience. Eligibility to act as a QP or willing to complete the qualification to act as a Qualified person. This job originally appeared on RecruitIreland.com.

2348 days ago