
C&Q Lead for new oral solid dosage (OSD) manufacturing facilities in Switzerland, focusing on equipment qualification, ensuring GMP compliance, and overseeing pharmaceutical validation.
With over 20 years of experience in pharmaceutical validation and construction management, we ensure GMP compliance and rigorous equipment qualification under GMP, FDA, and AIFA standards.
As a clean utilities specialist, we focus on WFI, purified water, clean steam, HVAC, and compressed air commissioning, ensuring equipment qualification for GMP compliance and supporting pharmaceutical validation.
CTOP and VTOP documentation review, walkdowns, and turnover package management are essential for ensuring equipment qualification, GMP compliance, and effective pharmaceutical validation.
Project delivery for Bristol Myers Squibb, GSK, Bayer, Biogen, CSL Behring, and Thermo Fisher Scientific, focusing on equipment qualification, GMP compliance, and pharmaceutical validation.
The equipment qualification process for bioreactors, isolators, autoclaves, freeze dryers, and cleanroom HVAC systems is essential for ensuring GMP compliance and supporting pharmaceutical validation.