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James Culyer


Education and Professional Membership

  • BSc (Hons) Chemistry
  • Pg Dip Pharmaceutical Quality and Good Manufacturing Practice
  • Member of the Royal Society of Chemistry


James is a Quality Consultant and Qualified Person (since 2010) with over 20 years’ experience in technical, quality and managerial roles within parenteral, non-sterile liquid, oral solid dosage, and inhalation product manufacture.  He has extensive experience of managing all aspects of Manufacturing Site Quality Management Systems, and is a specialist in global Supply Chain Assurance activities.

James has significant experience of a wide range of medicinal product dosage forms, Medical Devices and Medical Device Quality Management, Supplier and Supply Chain Risk Management, development and implementation of all elements of QMS, facility GMP design, new product introduction/product launches, and GMP training.

Based in South Africa and specializing in support of Emerging Markets and Global Supply Chain Activities, James can provide the following support services:

  • Full Supply Chain Quality Auditing Services
  • Support of Due Diligence Activities
  • Qualified & Responsible Person Services
  • Quality Risk Management
  • Quality Management System Support and Review
  • Inspection Preparation and Remediation
  • QA/GMP Project Consultancy – Facility Refurbishment & Green Field Projects, Product Launches
  • GMP & GDP Training
Email James Culyer