Senior R&D QA GCP Auditor - UK

• Position: Senior R&D QA GCP Auditor – UK
• Job type: Permanent
• Employment hours: Full-Time
• Salary: Competitive Salary and Bonus

About the role

Senior R&D QA GCP Auditor – UK

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

Your role will be to ensure compliance with the correct application of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) in the clinical development of Global R&D projects in UK and EU environments.

Key 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, and clinical service providers supporting clinical trials under UK and EU requirements.
• Management of the audit process from the agenda to the finalization of audit reports.
• Support Global R&D Departments and Global R&D QA Auditing & Supplier Qualification Unit in managing findings (non-conformities) from audits.
• Assist the Unit Head in collecting information for the preparation of the annual audit programme for GCP and GCLP auditing activities.
• Support the monitoring and 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 a GCP-GCLP auditor in a pharmaceutical company or Contract Research Organization (CRO).
• Clinical trials management experience on investigational medicinal products as a Clinical Research Associate (CRA) or Clinical Project Manager (CPM) in a pharmaceutical company or CRO.
• Knowledge of GCP-GCLP requisites under UK and EU requirements.
• Knowledge of auditing techniques.
• Knowledge of training techniques.
• Knowledge of the pharmaceutical development process, specifically the clinical development phases and management of investigational medicinal products in clinical trials.
• Proficiency with principal informatic systems (Word, Excel, Outlook, PowerPoint) and Trackwise for managing audits 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.

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