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12.06.2016

Document Management Specialist

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Switzerland.

Our client is a world leader in their field. Being a reputed Medical Device Company, they develop and produce innovative dental restorations. They offer a great workplace with opportunities to grow and gain recognition for your effort and achievements. They are listed on the Fortune 500.

ROLE DESCRIPTION

Within the role of Document Management Specialist (10 months contract position) you will be responsible for 3 pillars: Document control, Training processes & Change control. As part of the Quality Department you will assist and collaborate closely with the R&D department. Within this role you will report directly to the Director of QMS, Doc Control & Training.

RESPONSIBILITIES

-Take responsibility over GMP complaint handling of SOP’s and other documents
-Maintain the Learning Management System (LMS)
-Provide support to further develop the Quality Management System
-Development & maintenance of trainings and training plans
-Administrate the Change Management processes
-Daily management of Change Control for document changes and software
-Manage accounts and access management in SAP
-Ensure all documents, trainings and documents are handled in accordance with established processes and related regulations.
-Collaborate with all LMS Administrators to provide trainings and forums.

REQUIREMENTS

-3 to 5 years of experience within a similar role in a company regulated by the FDA
-Knowledge of Medical Device regulations from Japan, USA & EU
-Experience in the development of quality trainings in a MedDev environment (huge plus)
-Good IT knowledge & able to facilitate process harmonization
-Experience with SAP
-Focus on quality and a reliable personality who works well in teams
- Academic education in a related field

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.



 
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