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<strong>Lead Investigator<br><br></strong><strong>Location: </strong>Craigavon or Dundalk<br><br><strong>Hours: </strong>37.5 hours per week<br><br><strong>Salary: </strong>Competitive<br><br><strong>Business Unit</strong>: Clinical Services<br><br><strong>Open To</strong>: Internal & External Applicants<br><br><strong>Ref No.:</strong> HRJOB10960 <em>(Please note this is a re-advertisement, if you have applied for this position within the past 6 months, we will be unable to accept your application at this time)<br><br></em><strong>ㅤ<br><br></strong><strong>The Role<br><br></strong>The Lead Investigator plays a pivotal role in upholding the Pharmaceutical Quality Management System by ensuring that Deviations and Complaints (QEs) are thoroughly investigated and resolved through timely and effective Corrective and Preventative Actions (CAPAs).<br><br>This position requires conducting detailed investigations to assess impact, identify root causes using structured analysis tools, and implement measures to prevent recurrence. The Lead Investigator must document findings clearly and concisely using authorized systems, ensuring transparency and compliance with regulatory expectations.<br><br>In addition to managing investigations, the Lead Investigator is responsible for engaging directly with affected departments, conducting on-site assessments (including travel between CR and DK sites), and facilitating open communication to gather accurate information. The role involves regular updates to management, participation in customer discussions, and collaboration across departments to ensure global alignment on CAPAs.<br><br>The Lead Investigator is also expected to monitor investigation progress, verify CAPA effectiveness, and contribute to continuous improvement initiatives through active participation in team meetings and process enhancement discussions.<br><br><em>Full details of the job role can be found in the Job Description attached at the bottom of this job advert.<br><br></em>ㅤ<br><br><strong>Key Requirements<br><br></strong><ul><li>Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time employment in the UK</li><li>GCSE mathematics or equivalent (Grade C or above)</li><li>Degree level qualification OR Significant relevant work experience and subject matter knowledge will be considered in lieu of a degree</li><li>Industry experience within a pharmaceutical or relevant regulated / healthcare environment</li><li>Experience in the analysis of data using IT applications as well as presentation of this data in concise reports.<br><br></li></ul><em>Please note further desirable criteria contained within the Job Description attached at the bottom of the job advert.<br><br></em>ㅤ<br><br><strong>Further Information<br><br></strong>The working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with a minimum requirement of 5 hours per day.<br><br>This role will be eligible for hybrid working after successful completion of probation period.<br><br>ㅤ<br><br><strong>Apply Now<br><br></strong>Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.<br><br><strong>ㅤ<br><br></strong><strong>Closing Date<br><br></strong>We will no longer be accepting applications after 5pm on <strong>30 Sept 2025<br><br></strong><strong>ㅤ</strong>