Senior R&D QA GCP Auditor - UK

About the role

Senior R&D QA GCP Auditor - UK

Our client is a privately-owned Company which allows them the freedom to decide which research they invest in. They have a strong code of ethics and conduct and have a commitment to ethical and social responsibility. They have medicines within Cardiovascular, Neonatal, Transplantation, Respiratory, and have an exciting speciality pipeline.

Your role will be to ensure 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.

Key responsibilities include:

• 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

Candidate profile:

• Experience as GCP-GCLP auditor in pharmaceutical company or Contract Research Organization (CRO)
• Clinical trials management experience on investigational medicinal products as Clinical Research Associate (CRA) or Clinical Project Manager (CPM) in pharmaceutical company or CRO
• 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
• Ability with the principal informatic system (Word, Excel, Outlook, PowerPoint), ability with Trackwise for the management of the audit and findings (non-conformities) from audits and the management of clinical service providers

An excellent salary and benefits package will be offered.

Please apply online or contact CHASE for further information on 0131 553 6644.

Reference Number: 34101