Biotech and Agricultural Engineering Management & Business Others Other Science and Tech Others
January 14, 2020
QA Officer (Fixed)
Thermo Fisher Scientific Lelystad is the Center of Excellence for the production of Animal Health products. The QA Officer works under the supervision of the QA Manager & QA Team Leader to provides focus for the Global Quality Management System (QMS) and working closely with manufacturing and other departments to promote consistency, continuous improvement and compliance with Global/Site quality and business requirements.
Ensure the GMP and ISO9001:2015 standard is maintained and improved when necessary.
Assist in coordinating approaches and planning for customer /notified body/corporate audits.
Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
Manage investigations on Trackwise including Complaints, NCM, CAPAs, PRs and Audit Observations.
Coordinates Quality Assurance (QA) activities and programs such as auditing, record review, final product functions, complaints, document management, oversight of quality systems and/or investigations within QA.
Complies with all job-related safety and other training requirements. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
Practise excellent customer service whilst supporting the timely resolution of complaints.
Take an active role in the customer notification process ensuring change notification is effectively managed and customer needs are always considered.
Train others, to the appropriate level in an operation, and update training records.
Utilise the Agile system to maintain process procedures as well as SOP’s to ensure that all work instructions are current and accurate.
Work with the QA team to focusing on improvement projects to improve product quality e.g. complaint reduction or yield/process improvements.