Principal QA Auditor (GCP)

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Norfolk, England
Posting date: 06 Oct 2020

This is an exciting opportunity to join a CRO team reporting to the QA Manager, you will provide day-to-day support to the quality assurance function. You will be responsible for assisting in the management of the Quality Assurance program and will work with other departments to assure regulatory compliance and consistency with the policies and procedures.

Job Responsibilities

  • Set up the annual quality audit programme
  • Ensure the quality audit programme is followed and kept up to date
  • Conduct reporting and follow-up of quality system, computer system validation and service provider audits
  • Ensure audit results are formally recorded and reported and that corrective/preventative actions are documented
  • Maintain the approved service provider list
  • Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA
  • Production of the annual trend analysis using QA metrics
  • Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)
  • Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits

Skills and Requirements

  • GCP and CSV QA experience
  • Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies
  • Experience in the management of documents (Policies, SOPs etc.)
  • Expert knowledge of GCP and applicable regulations
  • 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

To Apply

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