Quality Management and Quality Assurance

All activities within a company, which influence the condition (quality) of a product or service, have to be coordinated. The measures required for this purpose are referred to as Quality Management. A Quality Management system which is required, e.g. in the manufacturing of pharmaceuticals, is in accordance with the guidelines of Good Manufacturing Practice (GMP)

Required qualifications

  • In general academic degree
  • Prevalently pharmacists, as well as biologists, chemists, medical veterinarians, engineers with complying additional training

Job profiles (examples)

  • Quality Control Manager
  • Quality Assurance Manager
  • Qualified Person According To § 14 AMG and § 15 AMG
  • CAPA Management
  • HSE Manager
  • Quality Management Representative (QMR)
  • Validation
  • Expert CGMP's (especially FDA 21 CFR Part 820 and Part 11) - FDA guidelines for medical devices for the Quality System for the US
  • Expert ISO 13485
  • Auditors (GLP, GCP, GMP, GSP, GDP, FDA Mock Audit, Supplier Audits)
  • IT Validator Pharma According to ICH, ISO, GMP, FDA

Your direct contact

An der Gnadenkirche 10
46485 Wesel

+49 281 300 84 24