QA Consultancy

With more than two decades of hands-on experience in pharmaceutical quality assurance, I help companies build, refine, and maintain inspection-ready Quality Management Systems (QMS). My consultancy work includes batch record review, change control management, CAPA systems, and document oversight — aligned with EU GMP, GDP, ISO, and FDA expectations.

I have worked with both startups and global market leaders such as Pfizer, Janssen, Moderna, and Merck to elevate quality systems. My strength lies in translating complex regulations into practical, efficient processes that integrate seamlessly into your organization.

Clients regularly trust me to lead or restore QMS improvement projects following inspection findings. I have redesigned documentation systems, built training programs, improved product quality review processes, and implemented integrated deviation and CAPA frameworks that withstand rigorous Health Authority scrutiny.