Quality Specialist - Silverton, OH, United States - NovaWorks
Description
At Madaus GmbH (a Viatris Company) in Troisdorf (near Cologne/Bonn), we produce pharmaceuticals and phytopharmaceuticals in various forms for both the German and international market with over 400 employees.
For our traditional and continuously growing production site, we are currently seeking a full-time Quality Specialist (m/w/d) for our Quality Management department on a fixed-term contract for 2 years.
Your responsibilities:
- Support the Quality Management department in developing and implementing an automation concept for laboratory systems (Project: Laboratory Automation)
- Evaluation of systems in terms of integration with LIMS (Paperless Laboratory)
- Creation of qualification and validation documents for systems in the analytical environment (e.g. photometers, scales, titrators)
- Support in conducting qualifications and validations of computerized systems
- Creation of training materials, adaptation and creation of relevant procedures and work instructions, as well as training employees (m/w/d) on validation and qualification requirements
Your profile:
- Completed degree in natural sciences or equivalent education (e.g. chemical laboratory technician, chemical engineer, PTA)
- Several years of professional experience in quality management in a pharmaceutical company, preferably in the field of chromatography (e.g. HPLC, GC/HS)
- Excellent knowledge of chromatography software (Empower) and LIMS (Labware) required
- Familiarity with pharmaceutical regulations in a GMP environment
- Excellent German and English skills, both written
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