Quality Specialist - Silverton, OH, United States - NovaWorks

NovaWorks
NovaWorks
Verified Company
Silverton, OH, United States

3 weeks ago

James Miller

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James Miller

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Freelance
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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