Quality Assurance Auditor - GCP
£35,000 - £45,000 + 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 an ongoing COVID-19 project 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 Quality Assurance Auditor, who will ensure my client are compliant with MHRA, GCP and company specific SOP's and regulations. The successful candidate 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 Quality Assurance Auditor - GCP 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 Quality Assurance Auditor - GCP vacancy, you will need the following skills and experience;
- BSc/MSc in a relevant scientific subject (Biomedical Science, Biochemistry, Pharmacology, Biotechnology etc.) or equivalent relevant working 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) and MHRA regulations. GMP, GDP and/or Pharmacovigilance (PV) knowledge would also be beneficial.
- 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 be eligible to work in the UK. Learn more
- Agency: SRG
- Contact: Katie-May Kress
- Phone: 0203 096 4711
- Reference: J34437
- Posted: 22nd February 2021
- Expires: 22nd March 2021