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Anna J
@annajamesq
GMP Compliance Support
Royaume-Uni
Espagnol, Français, Néerlandais
À propos de moi
Hello, I’m Anna James.
I’m detail oriented, organized, and passionate about quality, structure, and doing things the right way. I enjoy helping people bring clarity to complex work and turning messy information into clear, reliable results.
I value professionalism, communication, and delivering work people can trust. When I take on a project, I treat it with responsibility and care from start to finish.
Outside of work, I enjoy learning new skills and continuously improving myself.
Compétences
Anna J
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Rédaction technique
I will create professional gmp sop for pharma or medical devices
Rédaction technique
I will prepare you for gmp or fda inspection with mock audit questions
Portfolio
Expérience professionnelle
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GMP / Regulatory Compliance Sop Writer
Fiverr • Freelance
Mar 2024 - Present • 2 yrs 5 mos
Author Standard Operating Procedures (SOPs) and regulatory compliance documentation for pharmaceutical and life sciences processes, including GMP frameworks aligned with 21 CFR Part 210/211 requirements. Developed a comprehensive SOP establishing a Pre-Approval Inspection (PAI) readiness framework for New Product Introduction (NPI), covering cross-functional responsibilities, RACI matrices, phase-based process workflows, and inspection preparation timelines. Skilled in translating complex regulatory requirements into clear, structured, audit-ready documentation including guiding principles for data integrity, risk-based inspection preparation, and coordination with external manufacturing and testing partners (CMOs/CTLs). Experienced in supporting quality assurance teams with documentation that withstands regulatory scrutiny and mock inspection review.
