Senior GCP Auditor

2 days ago

Chippenham, Wiltshire, United Kingdom Chiesi Group Full time
Job Summary

Chiesi Group is seeking a highly experienced Senior GCP Auditor to join our team in ensuring the compliance and correct application of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) in our clinical development projects.

Key Responsibilities
  • Conduct first-party audits and mock inspections within our Global R&D departments to ensure compliance with GCP and GCLP regulations.
  • Perform second-party audits (remote and on-site) of Contract Research Organizations (CROs), Clinical Laboratories, Trial Master Files, investigational sites, and clinical service providers to ensure compliance with UK and EU requirements.
  • Manage the audit process from agenda creation to finalization of audit reports.
  • Support the Global R&D Departments and Global R&D QA Auditing & Supplier Qualification Unit in managing findings (non-conformities) from audits.
  • Assist in collecting information to prepare the annual audit program for GCP and GCLP auditing activities.
  • Monitor and update the annual audit program for GCP and GCLP auditing activities.
  • Finalize and review SOPs related to GCP-GCLP auditing activities.
  • Organize training on GCP-GCLP regulations and procedures under UK and EU requirements.
Requirements
  • Knowledge of GCP-GCLP requirements under UK and EU regulations.
  • Knowledge of auditing techniques.
  • Knowledge of training techniques.
  • Knowledge of the pharmaceutical development process, specifically clinical development phases and management of investigational medicinal products in clinical trials.
Desirable Skills
  • Leadership skills.
  • Organizational skills.
  • Independent judgment and objectivity.
  • Team working skills.
  • Networking skills.
  • Decision-making skills.
  • Ability to listen.
  • Orientation to efficiency.
Technical Requirements
  • Microsoft Office (Word, Excel, Outlook, PowerPoint).
  • Experience with Trackwise (or similar electronic system) for managing audits and findings (non-conformities) from audits and clinical service providers.

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