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
Qualifications
- 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;
Additional Information
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.
About the Company
Eurofins Central Laboratory is a dynamic, global organization fully dedicated to providing global central laboratory services to support all phases of clinical trials. At Eurofins Central Laboratory, we are BOLD. We go beyond the expected. Since we are purely a central laboratory, there are no distractions allowing us to remain laser focused on the best science, technology and people.
We are part of one of the world’s leading laboratory organizations Eurofins Scientific, therefore we offer end-to-end testing solutions which are unsurpassed in the industry. Eurofins Central Laboratory is setting new standards with GLP capabilities embedded within our Central Laboratory. We support our customers with laboratory facilities in the USA, Europe, Singapore and China, and a back office in India.