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annajamesq

Anna J

@annajamesq

GMP Compliance Support

Reino Unido
Espanhol, Francês, Holandês
Algumas informações são exibidas no idioma inglês.
Sobre mim
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.... Saiba mais

Habilidades

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annajamesq
Anna J
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Tempo médio de resposta: 1 hora

Conheça meus serviços

Redação Técnica
I will create professional gmp sop for pharma or medical devices
A partir deUS$ 50 /projetoMais detalhes
Redação Técnica
I will prepare you for gmp or fda inspection with mock audit questions
A partir deUS$ 50 /projetoMais detalhes

Portfólio

Experiência profissional

Fiverr

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.