Dublin (City), Leinster (IE)
13 Apr 2021
05 May 2021
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)

My client, a global company with European Headquarters based in Dublin have a new opportunity for a Senior QA Auditor.

You will be part of a dynamic team.  The Quality Assurance team provides support to all sides of their business. Working on complex QA matters across the business, the QA team delivers on projects internally and externally.

The Role

  • Leading on external audits and inspections including scheduling, preparation, and hosting.
  • Supporting inspection readiness activities, including inspections of external sites.
  • To lead CAPA management for external audits and regulatory inspections where needed, in order to assure responses are compliant with SOP requirements, Good Clinical Practice guidelines and relevant regulations, including ensuring appropriate corrective and preventative actions are put in place and CAPAs are followed until resolution.
  • Preparing root cause analysis on quality issues including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs.
  • Manage inspection readiness activities.
  • Lead CAPA management for inspection, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution.
  • Identify and track required effectiveness checks and ensure effectiveness checks are completed within the require timelines.

This role will include post COVID travel of up to 35%.

What you need

  • Background in medicine, science and/or other relevant discipline and appropriate experience.
  • Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
  • Experience in hosting external audits and/or regulatory inspections
  • Knowledge of CAPA management, including performing effective root cause analysis
  • Experience in regulatory authority inspections an advantage
  • Knowledge of medical Device (MDDR) an advantage
  • Ability to review and evaluate clinical data / records.
  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators, and clients.
  • Detailed understanding of drug development and clinical trial process.
  • Good problem resolution skills.
  • Good planning and organizational skills with the ability to multi-task and prioritize effectively.
  • Ability to work efficiently and independently under pressure.

Show job spec on request. 

For full details call Tina at +353 1 2784701 or email your CV to tdunne@thornshaw.com


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