GCP Quality Assurance Auditor

GCP Quality Assurance Auditor - Cambridgeshire

Opportunity:

Are you currently working in clinical research? Have you conducted GCP audits to clinical trials? Looking for a new opportunity with a growing well respected organisation? Yes then this is the role for you.

Your role as a GCP QA Auditor will involve providing expert regulatory knowledge and excellent communication skills to assist with the design and implementation of the audit programme for the clinical development functions, including internal systems, external supplier and essential documentation and investigator site audits. You will also provide support, advice, education and training to other departments involved in clinical trials and pharmacovigilance activities and may become involved with GMP and GLP audits.

You will take part in hosting GCP and pharmacovigilance regulatory inspections; assist with the set up and maintenance of procedures within Clinical Development and support the development, maintenance and audit of marketing authorisation application dossiers.

This will be a broad based position, providing exposure to all aspects of drug development and marketing. Reporting to the Clinical QA Manager this is a highly interactive role, requiring self-reliance, effective strategic thinking and planning skills, the ability to network, operate within a busy team, and build influential relationships both internally and externally.

This is an excellent opportunity to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company.

This is a full time permanent opportunity. This role involves around 40% travel within the UK and overseas.

Skills:

To apply for the role of GCP Quality Assurance Auditor you will have the following:

• Ideally a bioscience degree or nursing qualification.
• Experience in GCP regulated clinical research essential.
• Proven experience in GCP investigator site auditing.
• Experience in post-marketing human medicinal product Pharmacovigilance, data management or a statistical background would be beneficial.
• A working knowledge of Oncology or Neuroscience would be advantageous.
• A full driving licence is required along with the ability to travel approximately 40% of the time both within the UK and overseas.

How to Apply:

If this sounds like the role for you or a colleague then please don’t hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.

To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.

If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.

Quality Start are acting as a specialist recruitment consultancy for this role.