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Principal QA Auditor (Clinical Phase II-III)

North Wales
Permanent
Reference: JR063595
Description

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

Our Principal QA Auditor will Perform QA contracted audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines and relevant regulations.

The Role:

  • Plan and conduct regular contracted audits (including standalone work) and for cause audits of the ICON quality system in order to evaluate the quality system against the requirements
    appropriate regulations and applicable guidelines.
  • Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action
  • Ensure that audit results are formally recorded and reported and that corrective/preventive actions are
    documented.
  • Assist with the development of the project audit procedures and scheduling of work
  • When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the operations and/or operational lead on all QA issues, including audit planning and review of audit results.
  • Keep the person to whom the QA Auditor reports to informed of any QA issues within the department that
    require attention.
  • Verification of audit CAPA completion where required by procedure
  • Travel (up to 35%) domestic and/or international, on occasion this may increase as a result of business
    needs.
  • Ability to apply general knowledge of business developed through education or past experience
  • Good understanding of drug development and clinical trial process.
  • Ability to review and evaluate clinical data/records/systems/processes
  • Knowledge and experience in performing and leading Root Cause Analysis
  • Well-developed interpersonal and communication skills (oral and written) with prior experience
  • conducting presentations or facilitating meetings.
  • Ability to work as part of a team.
  • The ability to liaise successfully with internal and external parties.
  • Oral and written fluency in the English language is required in order to communicate with personnel at multiple levels across the organization
  • Problem Solving skills: ability to use procedures to solve basic problems; analyze information and standard practices to make judgments
  • Competent computer skills including Microsoft Word, Excel, PowerPoint and Outlook
  • Good planning and organizational skills.
  • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license.
 

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