QA Officer

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