Job ResponsibilitiesPlan, execute and report audits according to the audit timetable and applicable procedures for the organization, subcontractors, s.....
Job Responsibilities
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.
Perform in life and operational spot inspections- generation of associated reports.
Monitor the progress, appropriateness and correct implementation of corrective measures.
Prepare, review and improve QA procedures.
Review procedures of other departments within the organization.
Provide quality-enhance training on your own initiative, annual compliance training, and on request.
Act as a contact person for quality questions from the organization.
Audit preparation, 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.
Job Requirements
Bachelor degree in Life Science or a Quality oriented education OR
MLO education with HLO work and think level
At least 2 years’ relevant work experience
Experience with or strong affinity with quality systems set up according to GCLP and/or GCP
Work experience in the field of ISO / IEC 17025 and 15189
Confident to engage in the discussion with the management
Excellent command of English, spoken and written
Able to increase the quality consciousness of employees
Strong analytical skills
Result oriented, sets him/herself concrete targets and does everything to achieve them, taking into account the common interest
Continuously focused on improvement and optimization of technology and the work process
Organizational talent, continue to perform effectively under pressure and know how to monitor progress
