Senior Auditor – Laboratory/GCP

Edit Job Requisition Additional Data: Senior Auditor – Laboratory/GCP - Hybrid - Dublin, Ireland<p></p><p><span>ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</span></p><p></p><p></p><p></p><p><b><span>Location: <span>Dublin, IE, </span>working within our Clinical Laboratory environment</span></b></p><p></p><p><span>Due the business function alignment of this role, there is a requirement for the individual to be <u>onsite at the Laboratory 3 out of 5 days</u>.</span></p><p><span> </span></p><p><b><span>The role:</span></b></p><p></p><p><span>We are looking for a Senior Quality Assurance Auditor to join our global vibrant and passionate Laboratory Auditing Team. You will partner with internal stakeholders, performing a variety of audit activities with our Laboratory environment.</span></p><p></p><p><b><span>Responsibilities will include (not limited to):</span></b></p><p></p><p><span><span>•<span><span>        </span> </span></span></span><span>Oversee change and risk management as it relates to laboratory practices (globally).</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Assist with relevant accreditation processes, in particular, the ISO 15189 Standards.</span></p><p><span><span>•<span><span>       </span> </span></span></span><span>Follow up on external inspections and verify the completion of corrective actions as</span><span> required by the reports of the inspectors.</span></p><p><span><span>•<span><span>       </span> </span></span></span><span>Participate in ongoing maintenance of the Quality Management </span><span>System (QMS) to current ISO 15189 standards, College of American Pathology (CAP), Good Clinical Practices (GCP) and other applicable laboratory standards.</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Support Performing tasks relevant to our Lab environment such as conducting internal audits against applicable laboratory standards.<span>  </span></span></p><p><span><span>•<span><span>       </span> </span></span></span><span>Participate in internal and external audits, as required.</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Providing advice to operations on quality related issues.</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Escalating quality and compliance issues to Quality &amp; Compliance Line Management and relevant ICON functions as appropriate.</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Performing Quality &amp; Compliance review of SOPs when designated this responsibility, and contribute to the development &amp; maintenance of departmental and general procedures.</span></p><p><span><span>•<span><span>        </span> </span></span></span><span>Support in root cause analysis practices. </span></p><p></p><p><b><span>Experience and qualifications required:</span></b></p><p></p><p><span><span>·<span><span>      </span> </span></span></span><span>Experience as a Quality Assurance/Compliance Auditor.</span></p><p><span><span>·<span><span>      </span> </span></span></span><span>Experience within a Laboratory or Clinical environment in an advantage.</span></p><p><span><span>·<span><span>      </span> </span></span></span><span>Experience with, with ICH-GCP and with relevant GxP regulations and guidelines.</span></p><p><span><span>·<span><span>      </span> </span></span></span><span>BSc Degree is required.</span></p><p><span><span>·<span><span>      </span> </span></span></span><span>Strong communication and relationship management skills.</span></p><p></p><p><span>#LI-Hybrid</span></p><p></p><p><b>What ICON can offer you:</b></p><p></p><p>Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p></p><p>Our benefits examples include:</p><ul><li><p>Various annual leave entitlements</p></li><li><p>A range of health insurance offerings to suit you and your family’s needs.</p></li><li><p>Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.</p></li><li><p>Life assurance</p></li><li><p>Flexible country-specific optional benefits, including childcare vouchers, bike purcha