Expert Gms Documentation - Frankfurt Am Main, Deutschland - Fresenius Medical Care

Fresenius Medical Care
Fresenius Medical Care
Geprüftes Unternehmen
Frankfurt Am Main, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

In your role as (Junior) Expert GMS Documentation (M/F/d) you will support the GMS Documentation and Training Office in the implementation, maintenance, and further development of the global core process for documentation control and the electronic document management system Windchill used for this in context of the Global Management System (GMS).

This position can be located within Europe.


Your tasks

Operational support in:

  • Implementation, maintenance, and further development of the global computerized document management system (e.g., user administration, troubleshooting (firstlevel support), user training)
  • Routine validity check of GMS controlled documents as part of the "periodic review" process
  • Document change requests, formal review of controlled documents
  • Archiving of records and obsolete controlled documents
  • Preparation and review of local implementation requests (LIR) on quality and regulatory requirements and associated Quality and Regulatory Implementation Support (QRIS) documents
  • Design and delivery of training, including preparation of appropriate training materials
  • Preparation of analyses, (status) reports and presentations on the processes for documentation control, document retention and document change control (e.g., input for management review)
  • Administration of electronic platforms used by the department for information exchange and storage of department documents (e.g., MS-Teams Team / MS
  • Sharepoint)

Your qualification

  • Completed scientific, medical or technical education at a technical college or university
  • First professional experience in the field of medical devices / pharmaceuticals
  • Preferably work experience in a multinational company
  • Basic knowledge of applicable normative and regulatory requirements for the medical device / pharmaceutical industry (e.g., ISO 13485, ISO 9001, ISO 14001, GxP, MDSAP)
  • Initial knowledge of electronic document management systems and/or integrated management system software solutions (e.g., PTC Windchill)
  • Good communication and analytical skills
  • Fluent written and spoken English; German language skills are an advantage
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