Quality System Engineer Lukácsháza

Quality System Engineer
Lukácsháza
Lukácsháza, Vas County, HU

  Our Business Unit Pharmaceutical Systems is one of the world’s leading manufacturers of drug containment solutions and delivery systems for injectable drugs. More than 600 production lines in 14 countries worldwide produce more than 10 billion syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer.   Quality System Engineer*   Your Contribution - 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   Your Profile - 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 2 years in Quality Management System - Good command of English   Your Benefits - SCHOTT’s openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans: everything geared to suit your goals and needs. Discover a special corporate culture where everyone has the opportunity to develop their entire potential. - *At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.