Consultant, Pharma Biotech

Email: pharmamail@nsf.org
Country: South Africa

James Culyer is a quality consultant and Qualified Person (since 2010) with over 20 years of experience in technical, quality and managerial roles within parenteral, non-sterile liquid, oral solid dosage and inhalation product manufacture. He has extensive experience managing all aspects of manufacturing site quality management systems and is a specialist in global supply chain assurance activities.

Mr. Culyer has practical experience of a wide range of medicinal product dosage forms – tablets, capsules, powders, sterile Injections (large-volume parenterals, vials, ampoules), transdermal patches, oral non-sterile liquids, inhalation products (pMDI), and creams and ointments. He also has experience with medical devices and medical device quality management. He has a degree in chemistry and a postgraduate diploma in pharmaceutical quality and Good Manufacturing Practice.

His areas of expertise include:

  • Full supply chain quality auditing
  • Due diligence activities
  • Qualified and Responsible Person services
  • Quality risk management
  • Quality management system support and review
  • Inspection preparation and remediation
  • QA/GMP project consultancy: Facility refurbishment and green field projects; product launches
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