QA Officer

Eurofins; Breda; On-site; EUR 40,000 - 55,000; Full time

Job summary

Eurofins in Breda, Netherlands is seeking a QA Officer to oversee quality assessments and coordinate QA processes. Candidates should have at least 2 years of relevant experience and a Bachelor's degree in Life Science. Responsibilities include planning audits and ensuring compliance with quality standards.

The ideal candidate will possess strong analytical and organizational skills, be confident in discussions with management, and have a good command of English. Join our dynamic team for a pleasant working environment.

Qualifications

• At least 2 years relevant work experience.
• Experience with quality systems following GCLP and/or GCP.
• Strong background with ISO / IEC 17025 and 15189 preferred.

Responsibilities

• Act as QA coordinator and perform quality assessments.
• Plan, execute and report audits according to procedures.
• Provide training on quality enhancements.

Skills

Quality systems (GCLP, GCP)

Analytical skills

Persuasiveness

Education

Bachelor degree in Life Science

Job description

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.

For our division Eurofins Central Laboratory we are looking for a QA Officer

Job Description

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) auditsand conduct in-life phase inspections as required for compliance with internal proceduresand bioanalyticalmethod validation guidelines (FDA, EMA);
• Perform review of raw data against the draft reports of bioanalytical studies to verify that the reportsaccurately 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 orMLO 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.