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Clinical Quality Senior Auditor / England

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Location: East Anglia, England
Clinical Quality Senior Auditor –  East Anglia / Remote - Permanent

A new role has come available for an experienced Quality Auditor to join an exciting Contract Research Organization in the UK. They are a leader in their market supporting Pharma, Biotech and Medical Device companies and are seeking a Senior addition to their Quality Assurance team.

Senior Quality Auditor Responsibilities:

  • Set up, management and reporting of the Quality Audit Programme, ensuring it is followed and kept up to date
  • QMS management and reporting as well as computer system validation
  • Involvement in and reporting of QMS CAPAs
  • Production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA
  • Trend analysis using QA metrics
  • Produce training documentation relating to quality and regulatory areas.
  • Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits
Senior Quality Auditor  Requirements:

  • QA Auditing experience in a regulated environment
  • Clinical GCP and CSV QA experience
  • Experience interacting with regulatory agencies
  • Experience in the management of documents (Policies, SOPs etc.)
  • Demonstrates leadership ability, communication, and facilitation skills
  • Be able to work on own initiative and able to function independently or as part of a team
In return you can expect a generous salary and package as well as the opportunity to progress your career at a highly reputable organisation. 

If you are interested please apply or contact me for more information.


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