Quality Performance

Operational Quality Assurance • Project Quality • Quality Control • Quality System • HSE

Area of expertise

OPERATIONAL QUALITY ASSURANCE

  • Production quality support
  • Batch record simplification / optimization
  • Support for the batch release process (CoC)
  • Support and optimization of Deviations / CAPA / Change Request management
  • Support for Complaint management (customer & supplier)
  • Support for supplier quality management
  • Support for annual quality reviews (data collect, analysis and visual management)

PROJECT QUALITY

  • Support for product / process development projects (quality by design approach)
  • Regulatory QA activities coordination for technology transfers to CMOS

QUALITY CONTROL

  • Regulatory QA activities coordination for technology transfers to CMOS
  • Support for incoming control (incl. delegation strategy)
  • Planning and sample flow management for laboratory controls
  • CoA Review / OOS & OOT management
  • Analytical methods/procedure & validation protocol management

QUALITY SYSTEM

  • QMS performance / Quality Culture
  • GMP Audits / Inspections readiness
  • Quality risk management-based approach
  • Data Integrity
  • Document management (writing & control) / Knowledge management
  • Training & Approvals

HSE  

  • Support for preventive actions implementation
  • Support for certification (ISO 14001, ISO45001, etc.)