Pozíció leírása:

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.

Amit kínálunk:

Elvárások:

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)

Quality System Engineer

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