GMP Inspector

Dublin (City), Leinster (IE)
22 Feb 2021
24 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

<p><strong>GMP Inspector</strong></p> <p><strong>On behalf of my client, I am recruiting for a GMP Inspector.</strong></p> <p>The successful candidate will report to a Senior Inspector and will be responsible for assessing manufacturers compliance with GMP. The role will involve inspecting, reporting and forming conclusions on the suitability of a site for the activities being performed. The Inspector will provide support to the enforcement and execution of national regulations in relation to medicinal products.</p> <p><strong>Key Responsibilities:</strong></p> <ul> <li>Writing and compiling inspection reports when acting as lead inspector and contributing to preparation of all other inspection reports</li> <li>&nbsp;Maintaining a database of all inspections performed</li> <li>Preparing for and performing inspections in accordance with organisation procedures</li> <li>Assist in the effective implementation of the organisation’s Quality Management System within the compliance department.</li> <li>Ensuring that Inspection procedures remain up to date with relevant developments in National, European and International regulations, legislation and guides</li> <li>Participate in performance development programme and take measures to identify and resolve issues impacting performance</li> <li>Participating, as required, at national and international seminars in the areas of GMP</li> <li>Responding to queries (technical and procedural) from internal and external customers</li> </ul> <p><strong>Qualifications/Experience:</strong></p> <ul> <li>A third level degree in a relevant scientific or related discipline</li> <li>A minimum of 3 years’ relevant work experience in either a medicinal product manufacturing site <strong>OR</strong> a regulatory authority performing GMP inspections</li> <li>Experience as a Qualified Person</li> <li>Experience at a management/supervisory level</li> <li>Knowledge of relevant European and national legislation and EU GMP guidelines</li> <li>Evidence of excellent communication, report writing and decision-making skills</li> <li>Evidence of excellent team working abilities and a proven ability to prioritise and deliver to timelines</li> <li>A full valid driver’s license and vehicle</li> <li>Ability to travel for national and international inspections</li> </ul>

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