Quality Manager / PRRC
Our client, a speciality Pharma company, is currently recruiting for a Quality Manager and PRRC to join their team on a permanent basis. The role will primarily cover the management of quality systems for Medical Devices, as well as GDP Compliance for the Medicinal product. The role is based in Dublin City Centre with hybrid working. Occasional travel outside of Dublin is required.
Responsibilities: Quality Management SystemBuild and maintain the Quality Management System (QMS)Create new SOPs and other quality documentsCarry out risk assessments and manage change controlsManage the internal and external audit program and conduct and co-ordinate audits as required, including GDP Self inspectionsOrganise, manage and monitor training via ETQ and maintain training filesMaintain the quality management system comprised of ETQ (document management system) documentation associated with company procedures ensuring audit-readiness at all timesHandle complaints and processing post-marketing requirements for medical devices within the specified timelines - In support of the PRRC PMS activitiesConduct corrective and preventative actions, oversee the CAPA log and report the progress of the CAPA at scheduled quality and annual management review meetingsManage warehouse including liaising with relevant company personnel ensuring receipt of regular inventory reports, addressing any storage excursionAct as the main point of contact with competent authorities and notified bodiesOversee the handling and maintain documentation supporting MDR, GDP, MDSAP and ISO standardsReport to management on the effectiveness of the quality management system and any need for improvementPrepare and arrange the annual management review meetingsEstablish and review ongoing KPIs and objectives for the Quality DepartmentEnsure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisationQuality Agreement ManagementProgress the application for MDD to MDR transition for Class IIa Medical DeviceLegal Manufacturer Activities - Medical DeviceComplete inspection of incoming raw materialsMaintain up to date design and development documentComplete final batch release approval including checks on batch documentation received from CMOEnsure the Technical Files are maintained and updated as requiredSupplier ManagementLead supplier management activities including supplier evaluation and maintain an approved vendor listingAct as point of contact within the Company for subcontracted activities carried out on behalf of the company, such as contracted manufacturing organisations (CMOs) and distributorsProvide pro-active support for subcontractors strategically leading and directing to ensure key deliverables are achieved on timeDevelop and maintain a relationship with CMOs to ensure a clear oversight of responsibilities assigned to subcontractorsPRRC - Carry out the required duties as per Article 15 of EU 2017/745, for various Medical Devices (Class I and Class IIa) including ensuring that:The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is releasedThe technical documentation and the EU declaration of conformity are drawn up and kept up to dateThe Post Market Surveillance obligations are complied with in accordance with article 10(10)The reporting obligations referred to in Article 87 to 91 are fulfilledRequirements: Meet the regulatory requirements of a PRRCBSc in Life Science / related disciplineExperience working with Medical Devices and knowledge of MDRKnowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, GDP 2013/C343/01For more information, please contact Sinéad Cullen on +353879500821 or ******
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