CGMP Consultant

Personal summary

I specialize in supporting pharmaceutical, biotechnology, and medical device organizations with GMP documentation and validation activities. My focus is on helping teams maintain compliance, reduce backlog, and stay on track during audits, facility expansions, and high-demand project periods. I provide hands-on support across: • SOP development and remediation aligned with GMP and regulatory expectations • CAPA and deviation investigations and documentation • Validation support, including IQ/OQ/PQ protocol writing and execution • Process, equipment, utilities, and cleaning validation • Audit readiness and quality system improvement I understand that many organizations are not lacking expertise—but are often constrained by time, resources, or aggressive timelines. I integrate quickly with internal teams to deliver practical, compliant solutions without adding unnecessary complexity. Whether you need support with a single SOP, a validation project, or broader quality system improvements, I focus on delivering work that is inspection-ready and aligned with your operational goals.

Skills

Process validation8 Good Manufacturing Practice (GMP)10 Project management5 Documentation9 Pharma / cosmetics10 Pharmaceuticals10