Reporting to the Senior Quality Engineer, the role is very much the 'go to' quality person on site during shift. The role is based with production with emphasis on QC Inspection, CAPAs, documentation checks and investigations. The role requires someone with high energy and the ability to work in a dynamic and fast paced GMP production site.
· Monitoring the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment.
· Preparation of relevant work sheets and execution of In Process inspection tests.
· Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process.
· Review In process controls, SOP's, Test Methods, and specifications to ensure Lab inspections are being carried out as per design intent.
· Analysis of data, quality metrics and trends of in-process inspection data.
· Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
· Preparation, review and approval of technical documentation and perform training as required in the area.
· BSc in a Science Related Field.
· 3+ years of experience in a QC lab with in a GMP environment.
· Experience in QC testing and QA activities
· Good knowledge of ISO standards and FDA
· Experience using SAP and Trackwise.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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