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Senior Clinical QA Auditor Cambridgeshire

Contract / Cambridgeshire, UK

Circa £45,000 DOE

Senior Clinical Quality Assurance Auditor South East

We are currently working with leading niche Pharmaceutical company who specialise is researching and developing prescription medicines to meet patient needs in a wide range of therapeutic indications. Along with the commercial roll out of their key product for patients with Multiple Sclerosis the company has a number of trials are planned for countries across the world

Overview

Reporting to the Clinical quality assurance manager this will be a broad based role which will allow you to get involved with and be exposed to all aspects of drug development and post-marketing data.

The role;

  • You will use your GCP auditing expertise, regulatory knowledge and excellent communication skills to support the audit programme for the clinical development and pharmacovigilance functions.
  • As part of the role you will plan, conduct and follow-up a number of different audits including;
  • Investigator site audits,
  • Process audits,
  • Vendor audits and;
  • Internal and documentation audits,
  • The role will include both UK & International travel
  • You will be expected to provide support, advice, education and training to other departments involved in clinical trials & pharmacovigilance activities,
  • There may also be an opportunity to train more junior members of the Clinical Quality Assurance team.
  • The role will include supporting GCP and PV regulatory inspections;
  • You will also set up, review and maintain the SOPs within Clinical Development and Pharmacovigilance and support the development, maintenance and audit of documentation intended for regulatory submission.

Experience required:

  • A Biological Science Degree
  • Proven experience in a GCP and/or PV auditing role
  • Experience in the conduct of most of the following audit types:- Vendor audits, Investigator Site Audits, Process audits, Pharmacovigilance audits, and Documentation audits
  • A full driving licence is a must along with the ability to travel approximately 50% of the time, both within the UK and overseas.

 

This is a 2-year Contract Position (40 hours per week), with about 80% of the time spent auditing

 

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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About us

Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

Contact

info@life-science.co.uk

0044 (0) 207 421 0000

0049 152 1164 1635

Resourcing Life Science Ltd.
Clerkenwell Workshops,
27/31 Clerkenwell Close,
London
EC1R 0AT