Kay Hukin Dr.

Kay is a PhD Microbiologist, a member of the Royal Society of Biology and is eligible to act as a Qualified Person under the permanent provisions.

Kay has worked in Pharmaceutical Quality roles for over 20 years gaining extensive experience of manufacturing, packaging and testing of commercial and investigational medicinal products. Her most recent industry role, before taking up a position with NSF, was with a contract development and manufacturing organisation in a Quality Director role. Kay joined NSF in August 2024.

Kay’s experience covers pharmaceutical requirements in QC, QA and manufacturing for a wide range of dosage forms, including oral solid dose, oral liquids, and sterile products (aseptically manufactured and terminally sterilised) both for commercial supply and for early phase development or clinical trial use. This includes all aspects of manufacturing, packaging and labelling, facilities and systems implementation, technology transfer and outsourcing both as a contract giver and acceptor, as well as importation to and from the EU and third countries. Kay also brings a strong knowledge of compliance and efficiency improvement strategies to improve right first time and reduce the cost of quality.

Kay is also an experienced international QA auditor of a wide range of pharmaceutical manufacturers, suppliers and distribution hubs in the UK, Europe and India.

Kay’s recognised expertise include:

• Solid, liquid dose and sterile manufacturing operations
• Early phase development and IMP
• Quality Management Systems
• Microbiology Laboratory Controls
• Supply chain and vendor management
• Regulatory Compliance
• QP development, training and mentoring