Eqms System Support and Training Specialist - Oberursel, Deutschland - Fresenius Kabi

Fresenius Kabi

Geprüftes Unternehmen

Oberursel, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

We are seeking a highly motivated individual to join our team at our Oberursel (Taunus) location as a eQMS System Support and Training Specialist.

In this role, you will be responsible for providing support, user management, and training for our Electronic Quality Management System (eQMS) using Trackwise.

Your assignments

Independently handle business support requests, analyze and evaluate business process errors, and address user inquiries to enhance the system. Identify solutions and implement them effectively
Create and revise work instructions
Design and develop new learning materials, including conducting user training as a global trainer (user manuals, training concepts, training schedules, training materials, and presentations)
Contribute to the validationcompliant operation of the eQMS, including change management and conducting periodic reviews
Collaborate with relevant teams to evaluate business process requirements and changes within the change management process, ensuring proper implementation
Perform testing activities such as regression testing, error analysis, and GxP compliant documentation

Profile:

Bachelor's degree in a natural science discipline with a minimum of 2 years of professional experience in the pharmaceutical industry, or a medicaltechnical background with a minimum of 35 years of professional experience
Experience with computerized systems in regulated environments, particularly in computer system validation (e.g., GMP 21 CFR Part 11, EU GMP Annex 11, GAMP 5)
Proficiency in training system users, providing user support for IT systems, and creating training documentation
Expertise in business process for change management in the pharmaceutical industry
Experience in project work and project management
Fluent in written and spoken English

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