Quality Assurance

  • Overall quality management system (QMS) responsibility
  • Development and review of standard operating procedures (SOPs), guidance documents, templates in collaboration with CTCs Directors (in accordance with GxP and ISO standards)
  • Risk-based internal audit program
  • Internal training program including GxP training
  • Risk assessment and management
  • Quality issue, deviation and complaint handling
  • External GLP, GMP and GCP audits
  • Risk based vendor assessment program
  • Development of quality systems in pharmaceutical and medical device companies