ICON Clinical Research

Quality Assurance Auditor

07 Apr 2021
07 May 2021
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Quality Assurance Auditor - Coventry, UK (OFFICE or HOME Working)

You now have a great opportunity to join the Accellacare team and be part of the Quality Assurance team as an Auditor. This position is located in Coventry, UK but can also be done remotely.

The Purpose of the Role is to perform Quality Assurance responsibilities including but not limited to:
  • Perform internal routine audits and training to ensure consistency and compliance of operations across Accellacare EMEA sites.
  • Act as the QA subject matter expert for Quality Issues. Support Operational Compliance Teams with root cause analysis investigations and development of CAPA (as required).
  • To work with Accellacare personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.

Key Accountabilities
  • Conducts site, process and vendor audits at Accellacare sites in line with Quality Assurance Department annual audit plan.
  • Produce concise and informative audit reports within defined timescales, with minimum review cycles and follow up with personnel to ensure Quality Issue process is followed.
  • Review and analyse audit report findings to identify trends and suggest process improvements
  • Perform compliance checking of Accellacare procedures and provide feedback and support to colleagues.
  • Act as a key point of contact for Accellacare EMEA staff, providing information and expert guidance on regulations and procedures

What you will have:
  • A degree or relevant qualification e.g. diploma, certificate, or relevant experience in clinical trials.
  • Minimum three years' experience in Clinical Quality Assurance within a CRO or Pharma organisation or equivalent environment
  • At least 2 years' experience as a Quality Assurance Auditor performing clinical quality audits e.g. investigator site audits, vendor audits (this would be expected for Senior role but not for QA Auditor)
  • Expert working knowledge of GCP guidelines, and quality regulations / expectations pertaining to clinical trials.
  • Experience of regulatory inspections e.g. MHRA, FDA
  • Experience of sponsor / CRO audit process
  • Excellent analytical and communication skills and a proven track record of interacting with customers
  • Extensive computer skills in Microsoft Office applications are essential.
  • High standard of written and verbal English
  • Ability to work independently, with minimal supervision, and be confident to make decisions and escalate accordingly.
  • Willingness to travel globally on a regular basis (approx. 35-40%)

Personal Profile
  • Be highly organised with a focus on quality and detail
  • Self-motivated with a high level of initiative
  • Assertive and persistent with a high degree of flexibility and able to work in a proactive and reactive environment with effective problem-solving skills
  • Excellent communication and interpersonal skills and the ability to communicate across the organization at all levels.


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