プロフィール詳細

プロジェクトを作成

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Shefali K.に依頼

Australia

Authorized Person | Pharmaceutical QA Consultant | GMP · TGA · PIC/S | Batch Review & Release

プロフィール概要

Quality Assurance professional with 4+ years of experience in GMP-regulated pharmaceutical and radiopharmaceutical environments. Currently working as an Authorized Person, with hands-on expertise in batch record review and product release, deviation and CAPA management, SOP development, document control, and change control. Experienced in compliance with PIC/S GMP, TGA, ICH, and GLP regulatory frameworks. Available for freelance consulting, regulatory writing, QMS support, and GMP advisory projects on a flexible, remote basis. Key services I offer: • Batch record review and disposition • SOP writing and review • Deviation and CAPA documentation • GMP gap analysis and audit preparation • Quality management system (QMS) support • Regulatory compliance consulting (TGA, PIC/S, ICH)

専門分野

• ☆ Pharmaceutical Manufacturing
• ☆ Bioprocess Development
• ☆ Clinical Trials
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Quality Assurance & Quality Control (QA/QC)

サービス

• Writing
• Product Development

Writing Technical Writing, General Proofreading & Editing

Product Development Stability/Shelf Life Testing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Officer - Laboratory Quality Assurance

GMP-regulated Pharmaceutical company

5月 2026 - 現在

Quality Assurance

GMP-regulated radiopharmaceutical company,

9月 2023 - 5月 2026

学歴

Master of Biotechnology

The University of Queensland

7月 2019 - 7月 2021

認定資格

• Certified Pharmaceutical GMP Professional

  Thermo fisher university

  5月 2026 - 現在