QA Officer

The QA Officer is responsible for acting as a QA coordinator within the organization, performing quality assessments on the operational processes and advising on improvements towards the departments.

Key Accountabilities

• Plan, execute and report audits according to the audit timetable and applicable procedures;
• 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 procedures 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

• 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 is a pré
• Bachelor degree in Life Science or a Quality oriented education or MLO education with HLO work and think level
• Confident to engage in the discussion with the management
• Excellent command of English, spoken and written
• Able to increase the quality consciousness of employees by your persuasiveness;
• Strong analytical skills;
• Organizational talent, continue to perform effectively under pressure and know how to monitor progress;

Do you meet the above profile and are you interested in an informal and pleasant working environment? We are looking forward to receive your CV and motivation letter in English.