About this role
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 organizationAudit preparation, hosting of client audits and/or regulatory inspectionsReview 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. Bachelor degree in Life Science or a Quality oriented education ORMLO education with HLO work and think levelAt least 2 years’ relevant work experienceExperience with or strong affinity with quality systems set up according to GCLP and/or GCPWork experience in the field of ISO / IEC 17025 and 15189Confident to engage in the discussion with the managementExcellent command of English, spoken and writtenAble to increase the quality consciousness of employeesStrong analytical skillsResult oriented, sets him/herself concrete targets and does everything to achieve them, considering the common interestContinuously focused on improvement and optimization of technology and the work processOrganizational talent, continue to perform effectively under pressure and know how to monitor progress What we offer: As an employer, we’re keen to look after our people with as much dedication as they look after our patients. That’s why we offer competitive salaries, excellent training and exceptional career prospects. We’re a growing and ambitious company, so there is huge potential here to develop with us and enjoy fantastic rewards in your career.
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Eurofins Mechem is an Equal Opportunities Company.