QA Manager stands for Quality Assurance Manager - Brookings, United States - BlueWave Solutions

Meredith Sinclair

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Meredith Sinclair

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Description

We are THE GMP-EXPERT with a passion for excellence.

With recognized GMP expertise in the life sciences industry, gempex implements projects for the introduction, optimization, and maintenance of quality assurance systems. With more than 80 employees at locations in Mannheim (DE), Sisseln (CH), Guangzhou, and Suzhou (CN), we work globally with renowned companies such as BASF, Bayer, Boehringer Ingelheim, CureVac, Evonik, and Merck. We are a family-friendly medium-sized company with a future and development perspective.

Your tasks

  • Independent implementation of QM projects from project initiation to completion
  • Planning and execution of project milestones
  • Qualification of pharmaceutical production facilities and equipment
  • Analysis and evaluation of pharmaceutical quality assurance systems
  • Validation and optimization of manufacturing processes
  • Qualified support for customers in all GMP-related issues
  • Development of GMP-compliant documentation (SOPs, risk analyses) in German and English

Your profile

  • Degree in process engineering, pharmaceutical technology, biotechnology, chemical engineering, or a comparable engineering or natural science degree
  • Several years of experience in the qualification and GMP environment or relevant experience in the pharmaceutical industry

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