Quality System Engineer

Munkavállalói juttatások

• Multinational atmosphere
• Competitive salary
• Bonus twice a year
• Flexible work schedule
• Home office opportunity
• Excellent commuting support

Feladatok

• 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.