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