Areas of Expertise
QMS Design and Implementation
I assist organisations in building robust Quality Management Systems from the ground up or optimising existing ones to improve efficiency and compliance. My experience includes successfully transitioning systems from paper-based to fully digital platforms to meet modern regulatory standards.
Authoring and maintaining Standard Operating Procedures and technical documentation that not only meet compliance requirements but are also practical and user-friendly for teams at all levels.
Audits and Inspections
Preparing for and hosting sponsor audits and regulatory inspections, conducting vendor qualifications, and driving root cause analyses with corrective and preventive action plans.
Who I've Worked With
I have experience working with a range of companies, from billion-euro world leaders to start-ups. Some of the companies I have worked with include Abbott, AbbVie, Bioreliance, Calachem, GSK, Moorfields Pharmaceuticals, National Milk Laboratories, Norbrook Laboratories, Nuritas, Pfizer, Piramal Healthcare, Renishaw Diagnostics, and Symbiosis Pharmaceutical Services.