Senior Contractor, GxPAssure
Senior Contractor, GxPAssure
Steven Nolan is a highly experienced Quality professional within the pharmaceutical industry, with a career spanning technical and management roles in both Quality Assurance and Quality Control. Steven has served as the most senior Quality authority in multiple organisations and is eligible to act as a Qualified Person (QP) under Article 49 of Directive 2001/83/EC, Article 53 of Directive 2001/82/EC, and HMR 2012 (amended).
Steven has defined, implemented, maintained, and updated Pharmaceutical Quality Management Systems at both site and corporate levels, supporting research and development, commercial manufacturing, clinical manufacturing, and unlicensed medicines. His expertise covers the manufacture, testing, and release of a broad range of dosage forms, including sterile and aseptic preparations, small volume parenterals, solid dose forms, antibiotics, inhalation products (aerosol and dry powder), radiopharmaceuticals, liquids, creams, and other formulations at development, clinical, and commercial scales.
Steven has extensive experience engaging with regulatory authorities, leading site inspections and audits, and successfully managing remediation programmes across various organisations. As a qualified Pharmaceutical Auditor/Lead Auditor, he has audited numerous actors within the pharmaceutical supply chain against ISO guidelines, GMP, GLP, GCP, and global regulations.
He is a member of the MC1 Expert Advisory Group for the British Pharmacopoeia, providing advice on drug product monographs, and serves as a QP assessor for the Royal Society of Chemistry, reviewing and approving third-party training courses for accreditation. Steven’s published work includes research in organic and biomolecular chemistry and pharmaceutical sciences