Quality Assurance Consultant
Available for consultation: audits, remediation, QMS planning and change, in-house training and personnel systems management advisor.
EU and UK GMP GLP GCP
FDA 21 CFR Parts 11, 50, 54, 56, 210, 211, 312
ICH Q7A, E2A, E6
Education
Honors Degree in Botany with Microbiology (Reading University, 1990)
Doctorate in Biochemistry and Molecular Biology (University of Cambridge, 1995)
LRQA & IRCA Lead Auditor: Quality management systems: pharmaceutical manufacturing and packaging (ISO9001, PS9000)
Experience
Strong biotechnology background in vaccine and anti-toxin manufacture. Twenty-five years in public and private sector. cGMP Quality Manager (twelve years); novel medicines for FDA, MHRA, EU/EEA, ICH and TGA controlled markets. Successful Specials Licence acquisition for
manufacture novel recombinant DNA-based medicines and anti-toxins.
IMP and API experience
APIs: specialist in therapeutic antibodies for fractionation from hyperimmune apheresis plasma. Extensive world-wide travel for supply chain verification. Novel drug registrations in UK, USA.
Advanced therapy medicines (ATMPs): e.g. rDNA, siRNA. Projects: (1) GMP biomanufacturing recombinant vaccine vectors for anti-tumour therapy (Clinical Study Phase I, Jenner Institute), (2) Transdermal patch delivery. (3) Anti-toxins, (4) rDNA antigen vaccines.
QMS
All quality management system processes and documentation (paper/electronic/hybrid/cloud).
FDA, MHRA
Hosted MHRA and FDA inspectors. All successful first registrations (1) Safety pharmacology and toxicology, (2) cGMP manufacturing licences, (3) ongoing successful surveillance and reassessment by competent authorities.
Training provider
Trainer in how to apply quality management systems to maintain organizational success. Bespoke and standard packages provided.
Calibration and Testing – UKAS accredited test and calibration laboratories – Compliance audits.