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Senior QA Auditor - GCP / Clinical Trials

London   •  £40000 - £55000 per annum + + Competitive Benefits  •  Permanent, Full time

Senior QA Auditor - GCP / Clinical Trials

£40,000 - £55,000 + Benefits

Permanent position, London Based

Do you have experience of conducting internal and/or external Audits in line with Good Clinical Practice (GCP) standards?

Would you like to work for a leading clinical research and development organisation with ongoing COVID-19 projects and exciting study pipeline?

Through their specialised clinical trial platform, my client plays a key role in drug and vaccine development across a range of infectious and respiratory diseases. Their state of the art clinical and laboratory facilities are based in Central London, where they are looking to bring on board a Senior QA Auditor - GCP / Clinical Trials, who will be responsible for conducting internal and external audits, including of suppliers and service providers throughout their entire supply chain.

This is an excellent opportunity to join a team of driven QA professionals, within an organisation leading the way with their clinical trial platform and playing a key role in drug discovery, development and COVID-19 advancements.

Key Responsibilities of the Senior QA Auditor - GCP / Clinical Trials will include;

  • Plan and lead internal audits including of facilities, systems and documentation in line with GCP Regulations.
  • Conduct external audits and assessments, including of suppliers and service providers.
  • Ensure the appropriate planning and execution of internal and external audit programs.
  • Prepare Audit reports and associated compliance documentation.
  • Feedback identified compliance gaps and queries to key internal and external contacts, leading the resolution and closure of these findings.
  • Produce technical and quality agreements, sharing these with relevant teams to ensure quality compliance.
  • Liaise with internal and external contacts to ensure quality compliance, including responding to audit queries and self-assessment questionnaires, and delivering internal compliance training as required.

To be considered for this Senior QA Auditor - GCP / Clinical Trials vacancy, you will need the following skills and experience;

  • Experience of leading internal and/or external audits in line with Good Clinical Practice (GCP) regulations and standards.
  • Previous demonstrable Quality Assurance experience, ideally gained within a clinical research environment.
  • Solid understanding of Good Clinical Practice (GCP) regulations. GMP, GDP and/or Pharmacovigilance (PV) knowledge would also be beneficial.
  • A Lead Auditor qualification is desirable e.g. ICRA.
  • BSc/MSc in a relevant scientific subject (Chemistry, Pharmaceutical Science, Biochemistry, Pharmacology, Biotechnology etc.) or equivalent relevant working experience.
  • Excellent communication skills and a personable nature, to support relationship building with internal and external teams.
  • Strong attention to detail and organisational skills, with a thorough approach.

Key Words "Quality Assurance, QA, Audit, Auditor, GCP Audits, GCP, Good Clinical Practice, Clinical Research, Clinical Research Organisation, CRO, Pharmaceutical, Biopharmaceutical, London"

Please apply online or call Katie-May Kress on 0203 0964711 for more information

You must have the right to work in the UK. Learn more

  • Agency: SRG
  • Contact: Katie-May Kress
  • Phone: 0203 096 4711
  • Reference: J34437
  • Posted: 8th November 2021
  • Expires: 6th December 2021


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