Bad Homburg, Germany
9 days ago
(Senior) Expert GMS Documentation (m/f/d)

Your tasks:

Within the MaCoSe/GMS Documentation and Training Office department as part of the Global Management System (GMS) and the corresponding predecessor systems, you will be responsible for

Establishment, maintenance and improvement of a global documentation system in accordance with the requirements of the Global Management System (GMS) and regulatory requirementsAdministration and further development of the electronic document control system QDOK Windchill (e.g. user administration, troubleshooting, user training)Routine review of controlled documents as part of the "Periodic Review"Processing document change requests and formal document checks and improving the GMS pre-submission documentsControl and management of regulatory documents, including distribution and archivingAdministration of necessary translations in cooperation with the Corporate Labeling OfficeSupport in the development of new documents on requestPreparation and review of Local Implementation Requests (LIR) and QRISDesigning and delivering of training courses and creation of corresponding teaching materials and toolsPreparation of analyses, reports and presentations on documentation processesCollaboration on projects, system implementations and improvement activities

Your profile:

Completed studies in a scientific, medical or technical fieldAt least 3 - 5 years of professional experience, preferably 2 years in the medical devices/pharmaceutical sector Professional experience in a multinational companyExisting user knowledge of electronic document control systems (e.g. QDOK Windchill) is an advantageVery good knowledge of MS Office and basic knowledge of normative and legal requirements (e.g. ISO 13485, ISO 9001, ISO 14001, GxP, MDSAP).Very good communication and persuasion skillsWillingness to familiarize yourself with new topics and good project management skillsAbility to work independently in the assigned area of responsibilityExcellent analytical and conflict resolution skills, proactive and solution-oriented approachStrong customer orientation and high level of commitmentVery good written and spoken English, other foreign languages an advantage

Our offer for you

There is a lot you can discover at Fresenius Medical Care , because we have a lot to offer. No matter what field you are an expert in and how much experience you have - for your professional future with purpose:

The option to work on the moveWhether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest oneA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized company

Location: Bad Homburg and internationally

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