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Senior GCP Auditor

2 months ago

Chippenham, Wiltshire, United Kingdom Chiesi Group Full time
{"h1": "Senior GCP Auditor", "p": "At Chiesi Group, we are seeking a highly skilled Senior GCP Auditor to join our team. As a Senior GCP Auditor, you will be responsible for ensuring the compliance and correct application of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) inside the clinical development of our Global R&D projects in UK and EU environments.

Your key responsibilities will 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, and 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

To be successful in this role, you will need:

* 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

Additionally, you will need:

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

If you have a scientific degree and 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), we encourage you to apply for this exciting opportunity.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

If you are a motivated and detail-oriented individual with a passion for GCP and GCLP, we look forward to receiving your application.

Please note that only applications submitted through our website will be considered.

Thank you for your interest in joining our team"}