Senior GCP Auditor, Global R&D QA

Purpose

To assure the compliance and the correct application of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) inside the clinical development of the Global R&D projects in UK and EU environments.

Profile

Relevant experience as a GCP-GCLP auditor in pharmaceutical companies or Contract Research Organization (CRO). Along with relevant experience in clinical trials management on investigational medicinal products as Clinical Research Associate (CRA) or Clinical Project Manager (CPM) in pharmaceutical companies or Contract Research Organizations (CRO).

Main Responsibilities

• Execution of first party audits and Mock Inspections inside Global R&D departments. 
• Execution of second party audits (remote and on-site) to Contract Research Organizations (CRO), Clinical Laboratories, Trial Master Files, investigational sites, clinical service providers supporting clinical trials under UK and EU requirements.
• Management of audit process starting from the agenda till the finalization of audit reports.
• Support Global R&D Departments and Global R&D QA Auditing & Supplier Qualification Unit in the management of findings (non-conformities) coming from audits.
• Support the responsible of the Unit Head in collecting information supporting the preparation of the annual audit programme for GCP and GCLP auditing activities.
• Support the monitoring and the updating of the annual audit programme for GCP and GCLP auditing activities.
• Finalization/review of SOPs relating to GCP-GCLP auditing activities.
• Organization of training on GCP-GCLP regulations/procedures under UK and EU requirements

Education

Scientific Degree

Role Requirements

Technical Skills

• Knowledge of GCP-GCLP requisites under UK and EU requirements
• Knowledge of auditing technique
• Knowledge of training technique
• Knowledge of the pharmaceutical development process, in specific of the clinical development phases and management of the investigational medicinal product in clinical trials

Management Skills

• Leadership
• Organisational skills
• Independent judgement and objectivity
• Team working
• Networking
• Decision making
• Ability in listening
• Orientation to efficiency

IT Skills

• Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience of using Trackwise (or another similar electronic system) for the management of the audit and findings (non-conformities) from audits and the management of clinical service providers.