Ian Ramsay Biography

Ian Ramsay

Having studied at Manchester University in the UK, Ian was awarded a degree in Microbiology. This academic course included a range of modules and study areas focusing on industrial application of microbiological sciences.

After graduating university, Ian entered directly into pharmaceutical manufacturing serving in a wide range of QC and QA roles. Ian has broad exposure to a wide range of dose forms and manufacturing processes.

Ian joined GlaxoSmithKline on a prestigious Graduate Recruitment & fast-track programme aimed at developing future leaders. This two-year programme saw Ian placed at two separate manufacturing sites offering a wide range of exposure & training. Ian spent a year supporting the manufacture of bulk, sterile Cephalosporin API serving in the QC function providing analytical & investigational support. Ian subsequently spent a year supporting a non-sterile solid oral dose and topicals manufacturing facility- again providing analytical support and increasingly frontline QA investigational and improvement activities.

Following completion of this two-year programme, Ian again moved manufacturing site to support a high-volume, high-cost, rapid-paced manufacturing site producing dry powder metered dosed inhalers. This role saw Ian providing a wide range of complex, front-line QA services in support of manufacture. Ian closely supported the Qualified Persons on site and provided advice and coaching to support batch certification. Ian led the investigation and management of several serious non-compliances and manufacturing issues affecting multiple batches representing millions of pounds- effectively managing these situations to successful conclusion.

Following his time working in non-sterile inhalers and solid oral dose, Ian moved to Belgium to take up a position in Global Quality Assurance with GlaxoSmithKline Vaccines. This global role saw Ian assume responsibility for Quality support, advice & oversight for multiple manufacturing sites worldwide. Focusing on aseptically manufactured influenza vaccines, Ian supported the regulatory inspections of several sites across a wide range of regulatory authorities. Site inspection readiness was assessed with targeted remediation, support and coaching pre and post inspection. Sites themselves were supported through inspection with ongoing coaching of experts, presenters and site leadership to help assure the best possible outcome. Ian also provided independent oversight of the manufacturing sites for global/corporate management.

After his time in industry, Ian took a role as a GMP & GDP Inspector with the Medicines and Healthcare Products Regulatory Agency (MHRA)- the regulatory authority for the UK. This role saw Ian planning, managing & executing regulatory inspections of pharmaceutical manufacturers and distributors across the UK and overseas. Ian was responsible for the assessment of quality, safety and compliance of sites versus current EU-GMP standards and regulatory expectations. During his time at MHRA, Ian was responsible for the management of sites with serious non-compliances including several high-profile IAG & CMT cases. These activities required a diverse range of inspection activities and regulatory decision making including making recommendations on licence restrictions and/or other regulatory action.

Ian is able to draw on a broad range of industry and Regulatory Inspection experience- both from an industry and regulator perspective.