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: 1st October 2021
- Expires: 29th October 2021