The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph.
I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials.
Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives.
We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.
We are currently looking for a Clinical Quality Assurance Auditor / Senior Clinical Quality Assurance Auditor.
This is a full-time permanent role and can be home-based in the EU where we have the ability to hire.
ResponsibilitiesEnsures that the Clinical Quality Assurance System meets the expectations of the GCPs and other applicable GxPs and follows an inspection readiness and continuous improvement approach at AIXIAL Group level.Actively participate in the development and planning of the annual audit program.Implements and coordinates internal quality control/audit activities at local and international level.Participate in the writing of Compliance Plans (quality plan, internal audit plan and training plan) on an annual basis and updates them as necessary.Coordinates the management of non-conformities with the teams and verifies the effectiveness of actions taken within the expected timeframes.As lead auditor, plans and conducts internal and external audits.Coordinate and follow-up of CAPAs for customer audits, Regulatory Inspection, internal and vendor audits.Improve and manage the clinical quality assurance system program to ensure compliance with regulatory requirements, company standards, and industry best practices.Oversee the development and maintenance of Standard Operating Procedures (SOPs) and ensure they are consistently followed.Manage aspects related to the preparation of customer audits/Inspections with relevant teams.Follow up customer audits and be responsible for inspections within the deadlines set by customers or inspectors.Oversee the implementation of CAPAs, check that corrective and preventive actions are carried out on schedule by acting as the main contact with the teams or subcontractors concerned, and ensure that the actions implemented are documented.Independently conduct Audits that can include Clinical Investigator Site, Vendors, internal process audit, GCP/GxP Document Audits (ICFs, CSR and Trial Master Files).Develop audit plans, and audit reports, and track audit findings to resolution.
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