Plan, execute and report audits according to the audit timetable and applicable procedures for the organization, subcontractors, suppliers, and other Eurofins Central Laboratory contacts.
Plan and execute protocol, laboratory and supporting data, and final report (interim, draft, final) audits and conduct in-life phase inspections as required for compliance with internal SOPs and bioanalytical method validation guidelines (FDA, EMA)
Perform review of raw data against the draft reports of bioanalytical studies to verify that the reports accurately and completely reflect the raw data generated
Monitor the progress, appropriateness and correct implementation of corrective measures
Prepare, review and improve QA procedures
Review and approve procedures of other departments within the organization
Provide quality-enhance training on your own initiative and on request
Act as a contact person for quality questions from the organization
Assist with the preparation and hosting of client audits and/or regulatory inspections
Review and evaluate adequacy of investigations and CAPA (corrective actions/preventive actions) reports.
Maintain current knowledge of standard requirements according to GCLP, GCP, GMP, CAP, ISO17025 and ISO 15189 guidelines related to the business process
Archive and document control duties as assigned by QA Manager
Perform other related tasks that match training and experience on request of the QA Manager