*Background must be in pharma NOT medical devices)
Senior R&D QA GCP Auditor (pharmaceuticals)
I'm looking to recruit a seasoned Senior R&D QA GCP Auditor responsible for ensuring compliance and proper implementation of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) within the clinical development of Global R&D projects in the UK and EU settings.
The ideal candidate should possess substantial experience as a GCP-GCLP auditor in pharmaceutical firms or Contract Research Organisations (CROs), as well as relevant experience in managing clinical trials involving investigational medicinal products as either a Clinical Research Associate (CRA) or a Clinical Project Manager (CPM) in pharmaceutical companies or CROs.
Responsibilities
* mock inspections and first-party audits throughout global R&D divisions.
* out, in accordance with UK and EU regulations, remote and on-site second party audits of Contract Research Organisations (CRO), Clinical Laboratories, Trial Master Files, investigational sites, and clinical service providers supporting clinical trials.
* of the audit process from the planning stage to the completion of the audit reports.
* global R&D departments, supplier qualification units, and global R&D QA auditing in managing audit results (non-conformities).
* the Unit Head's responsibilities in gathering data to aid in the annual audit program's preparation for GCP and GCLP auditing activities.
* in keeping the yearly audit programme for GCP and GCLP auditing operations updated and monitored.
* pertaining to GCP-GCLP auditing operations are finalised or reviewed.
* for training on GCP-GCLP rules and practices in accordance with EU and UK legislation
Requirements
* degree
* of GCP-GCLP requirements in the UK and EU
* of the auditing process
* of training methods
* the phases of clinical development and managing investigational medicines in clinical trials, as well as the pharmaceutical development process in general
* in leadership and organisation
* by Microsoft (Word, Excel, Outlook, and PowerPoint).
* of managing audit results (non-conformities) and clinical service provider management using Trackwise (or a comparable electronic system).
Contact details to apply today:
+441293778666
gjohnstone@barringtonjames.com