Quality System Engineer

Job description

• Ensures with his/her supervisor that the requirements of the relevant standards and guidelines are dealt with: relevant cGMP, ISO 9001 – Quality Management System (QMS), ISO 15378 – Primary Packaging Pharmaceuticals, ISO 13485 – Medical Devices, pharmacopoeias and other guidelines in the pharmaceutical environment.
• ISO 9001, ISO 15378, ISO 13485 – maintenance of certification status, monitoring of requirements, taking actions Participation in improvements, preparation for the audits, maintenance of the documents, managing changes.
• Support for planning and conducting internal audits, creating (+following up) the associated audit reposts and CAPA items, creation and monitoring / updating of the annual Internal Audit Program.
• Owner of CAPA management tool (software for CAPA management) and the related process. Issuing CAPAs, reviewing and approving CAPA results.
• Supporting maintenance of Document management system based on the Process Map

Required education and experience

• BSc or MSc in the field of any engineering or nature science, quality management, food or pharmaceuticals
• Quality experience in a manufacturing environment, minimum of 5 years in Quality Management System
• Good command of English
• Deviation and problem solving skills
• High proficiency in QMS standards, including ISO 9001; advantage: ISO 13485, ISO 15378 GMP and other pharmaceutical guidelines, SAP
• M365 knowledge
• Experience regarding auditing (internal or supplier)

Location        

• Vas county