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Services

Guarantee Quality from A to Z

Services

Guarantee Quality from A to Z

"We ensure that the quality of the processes is guaranteed with the aim of high-quality finished products"

GDP - Responsible Person

Responsibilities

  • GDP regulations
  • Laws and regulations
  • Licensing system
  • EU guideline 2013/C 343/01
  • Regulation 2019/6
  • RP responsibilities
  • Set up GDP quality management system
  • Outsourcing activities
  • Management review
  • Complaints, recall
  • Deviation control, CAPA, Change control
  • Self-inspection system
  • Risk management
  • Qualification & validation
  • Qualification of suppliers and buyers
  • Counterfeiting and Risks
  • Reception & storage of medicines
  • Traceability, status management, returns
  • Delivery and transport of medicines
  • Cold-chain

QA Specialist

Responsibilities

  • Deviations
  • CAPAs
  • Change control
  • QMS
  • Extend due date
  • Assess and prepare final products
  • Root Cause Analysis Tools
  • Label issuing and control
  • Organizing projects in a team context
  • Auditing and Inspections
  • Report writing
  • Perform process inspections
  • Checking procedures
  • Batch review
  • Strategy meeting
  • Performing "Gemba walks" within production
  • Complaints

Quality Engineer

Responsibilities

  • Deviations
  • CAPAs
  • Change control
  • Batch review
  • Logbook review
  • Updating documents
  • Procedures/documents review
  • Investigate deviations
  • Investigate malfunctions
  • Provide document training
  • Improvement projects
  • Quality assurance
  • Root Cause Analysis Tools
  • Report writing