プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Dr. Aruna T.に依頼

India

Freelance GCP Auditor and Scientific Writer | Clinical Development | Laboratory & Bioanalysis | CSV |

プロフィール概要

Clinical Quality Auditor & Scientific Writing Consultant with 20+ years in Pharma and CRO sectors. Certified ISO xxxxxxxxx Lead Auditor with deep expertise in GCP audits—covering clinical trial conduct, labs, bioanalysis including method validation and study sample analysis. Skilled in regulatory inspection readiness, event investigation, CAPA management, electronic compliance and CSV implementation. The scientific writing support includes preparation and review of protocols, Plans, BCP, Trial Risk Assessment, Regulatory Agency communications. Successfully supported global inspections (USFDA, EMA, WHO, ANVISA...), confirming compliance and data integrity across trial operations.

専門分野

• ★ Clinical Trials
• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Drug-Drug Interactions
• ☆ Bioavailability
• ☆ Clinical Trial Design
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Case Studies
• ☆ Science Communication
• ☆ Scientific Proofreading & Editing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, General Proofreading & Editing

Research Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

GCP Auditor, Managing Partner

QDraft Services LLP

1月 2025 - 現在

Head - Compliance and Scientific Affairs

Navitas Lifesciences Limited

9月 2019 - 3月 2023

学歴

Ph.D in Pharmacology

Manipal university

5月 2008 - 5月 2012

M. Pharm

Rajiv Gandhi University of Health Sciences

1月 2002 - 1月 2004

認定資格

• Software Testing Foundations: Test Techniques Software Testing Foundations: Test Techniques LinkedIn

  LinkedIn

  https://www.linkedin.com/learning/certificates/665ba518c54bd81c54513a1fde9d1a373d04cb29d21ce024eecf58630e68df10?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2024 - 現在

• Software Development Life Cycle (SDLC)

  LinkedIn

  https://www.linkedin.com/learning/certificates/a3d2af372674f7df96b4cb8792ed361c6ced1946a1550f0a77ab12e018ba6cc4?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2024 - 現在

• Programming Foundations: Software Testing/QA

  LinkedIn

  https://www.linkedin.com/learning/certificates/58be8ba35dca48e92f88bb1f847f181d3854d096705f1c5afea9897ece7220ce?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2024 - 現在

• Dynamic Application Security Testing

  LinkedIn

  https://www.linkedin.com/learning/certificates/fa92fbf8bb9797abd16cef83ef37b0c5d9b5b57ff20ff89fa3bfa41d9546d83a?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2024 - 現在

• Data integrity for computerized systems in GxP environment

  udemy

  http://ude.my/UC-f01524ef-bb82-48b6-8905-682ad2bc38e9

  4月 2024 - 現在

• Udemy logo Computer system validation & maintenance based on GAMP 5 2nd Ed

  udemy

  http://ude.my/UC-76de6474-0cdf-49a1-90ff-e5f87af134ef

  4月 2024 - 現在

• CSA - Computer System Assurance - enhancement to CSV in GxP

  udemy

  http://ude.my/UC-9fedc2ce-0cf5-4502-b493-df858ee5b3ea

  4月 2024 - 現在

• ISO xxxxxxxxxx-Compliant Cybersecurity: The Annex A Control

  LinkedIn

  https://www.linkedin.com/learning/certificates/1d619e7d83bc83bde9590f448526f729a66e5a944c90914f67d825aeb625fa14?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2024 - 現在

• Certified Quality Management System Lead Auditor

  TUV SUD

  6月 2023 - 現在

• ISO xxxxxxxxxx-Compliant Cybersecurity: Getting Started ISO xxxxxxxxxx-Compliant Cybersecurity: Getting Started

  LinkedIn

  https://www.linkedin.com/learning/certificates/2e7ba591a2a42aa91813af0d3095f3c88ca3194ee8f57a9499766225c7a25cf0?lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;FEyFcTomStWjPdvmGbCDsA==

  4月 2023 - 現在

• Medical Laboratory System and Internal Audit as per ISO xxxxxxxxxx

  Quality Council of India(QCI)

  6月 2020 - 現在

• Certificate in Biostatistics, Epidemiology and Research Methodology

  Manipal Academy of Higher Education

  1月 2008 - 現在