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 incr
SGD 3,500 - 4,000 / Monthly
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