Eqms System Support and Training Specialist
vor 3 Wochen
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 validation-compliant 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 medical-technical background with a minimum of 3-5 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
- Auf einen Blick- Standort:
- HessenOberursel- Karrierelevel:
- Berufserfahrene- Einsatzbereich:
- IngenieurwesenProjektmanagementQualitätsmanagement / Umwelt- Arbeitsverhältnis:
- UnbefristetVollzeit- Unternehmen:
- Fresenius Kabi- Referenznummer:
- 57608- Veröffentlicht am:
- 26.06.2023- Solange die Stellenanzeige online ist, können Sie sich schnell und einfach bewerben.
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