(Senior) Expert GMS Documentation
vor 4 Wochen
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 requirements Administration and further development of the electronic document control system QDOK Windchill ( 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 documents Control and management of regulatory documents, including distribution and archiving Administration of necessary translations in cooperation with the Corporate Labeling Office Support in the development of new documents on request Preparation and review of Local Implementation Requests (LIR) and QRIS Designing and delivering of training courses and creation of corresponding teaching materials and tools Preparation of analyses, reports and presentations on documentation processes Collaboration on projects, system implementations and improvement activitiesYour profile:
Completed studies in a scientific, medical or technical field At least 3 - 5 years of professional experience, preferably 2 years in the medical devices/pharmaceutical sector Professional experience in a multinational company Existing user knowledge of electronic document control systems ( QDOK Windchill) is an advantage Very good knowledge of MS Office and basic knowledge of normative and legal requirements ( ISO 13485, ISO 9001, ISO 14001, GxP, MDSAP). Very good communication and persuasion skills Willingness to familiarize yourself with new topics and good project management skills Ability to work independently in the assigned area of responsibility Excellent analytical and conflict resolution skills, proactive and solution-oriented approach Strong customer orientation and high level of commitment Very good written and spoken English, other foreign languages an advantageOur 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 move Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world Individual opportunities for self-determined career planning and professional development A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one A large number of committed people with a wide range of skills, talents and experience The benefits of a successful global corporation with the collegial culture of a medium-sized companyLocation: Bad Homburg and internationally
Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.-
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