Exp: 2-5 years; The QA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.DUTIES & RESPONSIBILITIES Support the planning, preparation, and implementation of trial specific, quality system, and vendor qualification audits and report findings to the auditees.Support the creation of SOPs required for the proper functioning of the clinical trial process. When instructed by QA Management, evaluate and update QA SOPs.Audit the quality of the clinical trials against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and escalate the issue immediately with the Project Manager; and if required, with Chiltern Senior Management.Conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
Desired Skills and Experience
QA Management , update QA SOPs , Support the planning , implementation of trial specific
- Quality Assurance