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annajamesq

Anna J

@annajamesq

GMP Compliance Support

Großbritannien
Spanisch, Französisch, Niederländisch
Einige Informationen werden in englischer Sprache angezeigt.
Über mich
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.... Mehr lesen

Kompetenzen

a
annajamesq
Anna J
offline • 
Durchschnittliche Antwortzeit: 1 Stunde

Meine Dienstleistungen

Technische Texte
I will create professional gmp sop for pharma or medical devices
Ab50 $ / ProjektWeitere Details
Technische Texte
I will prepare you for gmp or fda inspection with mock audit questions
Ab50 $ / ProjektWeitere Details

Portfolio

Arbeitserfahrung

Fiverr

GMP / Regulatory Compliance Sop Writer

Fiverr • Freiberufler

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.