EC legislation has increased the responsibility of the Qualified Person to include responsibility for releasing all clinical trial materials that are produced in-house
Cobra Biomanufacturing has appointed Nick Hill as director of quality and he will act as Qualified Person (QP).
Hill joins Cobra from his most recent position as technical director at Bio-Products Laboratories, Elstree, UK and brings over 17 years experience in pharmaceutical manufacture and quality control.
He has worked for several leading international pharmaceutical and scientific companies including Bio-Products Laboratories, Washington Group International, Boehringer-Ingelheim, and GSK. Nick will join Cobra's existing QP staff and will be based at Cobra's new Oxford facility.
"This appointment follows the commissioning of our new cGMP biomanufacturing facility in Oxford where we are manufacturing a range of diverse biologicals that include novel therapeutic proteins, viruses and DNA," commented David Thatcher, CEO, Cobra.
Under new EC legislation which came into effect earlier this year, the responsibility of a QP has increased substantially; these people are now responsible for releasing all clinical trial materials that are produced in-house.
In addition, the QP has the authority to release imported materials for clinical trials that have been manufactured outside the EU by GMP.
David Thatcher added, "We are delighted that Nick Hill has joined Cobra, further strengthening our QP team and demonstrating our commitment to quality as a driver throughout the business."
