Compliance Specialist - Senior

CPL

Limerick

An opportunityhas arisen for a Senior Compliance Specialist . You will have responsibility for the audit program and for managing site readiness and the execution of External Inspections. You will support and own the review and approval of investigations and corrective action plans arising from internal/external audit observations to assure that they meet the required site and Medical Device standards of investigations, corrective action plans and effectiveness checks. Key Responsibilities: You will be responsible for weekly and monthly Reporting of Site Compliance Performance metrics and tracking and trending of the data. You will be responsible as a Lead Auditor/Auditor for the execution of Internal Audits in support of the Internal Audit Schedule. You will support the creation, deployment, and maintenance of the internal audit schedule and approved auditors list. You will support and lead Quality and Compliance projects. You will support programs for the ongoing monitoring and improvement of the effectiveness of the Quality System. You will promote a culture of Regulatory Compliance and Risk Management throughout the organization. Required for Role: Bachelors Degree - Scientific or Engineering Discipline or equivalent related experience (RAC certification, ASQ - CQA, CQE or SCQE. Qualified Quality Lead Assessor and experienced auditor in a Quality regulated environment. Minimum of 4 years of working experience in the quality assurance / compliance audit environment required. Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments. For more information please contact fiona.robson@cpl.ie or telephone 061 208653. This job originally appeared on RecruitIreland.com.

2655 days ago