Quality Assurance Officer

1w1 week ago

Eurofins

Singapore, SG · Full-time · S$60,000 – S$95,000

About this role

Eurofins Scientific is an international life sciences company providing analytical testing services across industries like pharmaceuticals to ensure products are safe, authentic, and accurately labeled. As Quality Assurance Officer, you will plan, execute, and report audits for the organization, subcontractors, and suppliers according to applicable procedures and timetables.

Your day-to-day involves conducting protocol, laboratory, data, and report audits compliant with internal SOPs, FDA, and EMA bioanalytical guidelines. You will review raw data against draft reports to verify accuracy and completeness, while monitoring corrective measures for proper implementation.

Working within Eurofins' decentralized network of 950 laboratories in 59 countries with 65,000 staff, you will prepare, review, and improve QA procedures and approve those from other departments. Act as the contact for quality questions and assist with client audits and regulatory inspections.

Enhance quality consciousness through training initiatives and maintain knowledge of GCLP, GCP, GMP, CAP, ISO 17025, and ISO 15189 guidelines. Review investigations and CAPA reports, perform archiving duties, and take on related tasks as assigned by the QA Manager.

Requirements

Bachelor degree in Life Science or 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 according to GCLP and/or GCP
Work experience in the field of ISO / IEC 17025 and 15189
Confident to engage in discussion with management
Excellent command of English, spoken and written
Able to increase the quality consciousness of employees
Strong analytical skills and result oriented

Responsibilities

Plan, execute and report audits according to the audit timetable and applicable procedures for the organization, subcontractors, suppliers, and other contacts
Plan and execute protocol, laboratory, data, and final report audits and conduct in-life phase inspections for compliance with SOPs and bioanalytical guidelines (FDA, EMA)
Perform review of raw data against draft reports of bioanalytical studies to verify accuracy and completeness
Monitor progress, appropriateness and correct implementation of corrective measures
Prepare, review and improve QA procedures
Review and approve procedures of other departments
Provide quality-enhance training on initiative or request and act as contact for quality questions
Assist with preparation and hosting of client audits and regulatory inspections