Senior R&D QA GCP Auditor

*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
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