Profile Details

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USD 70 /hr

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Hire Dr. Aruna T.

India

USD 70 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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)

Work Experience

GCP Auditor, Managing Partner

QDraft Services LLP

January 2025 - Present

Head - Compliance and Scientific Affairs

Navitas Lifesciences Limited

September 2019 - March 2023

Education

Ph.D in Pharmacology

Manipal university

May 2008 - May 2012

M. Pharm

Rajiv Gandhi University of Health Sciences

January 2002 - January 2004

Certifications

• 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==

  April 2024 - Present

• 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==

  April 2024 - Present

• 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==

  April 2024 - Present

• Dynamic Application Security Testing

  LinkedIn

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

  April 2024 - Present

• Data integrity for computerized systems in GxP environment

  udemy

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

  April 2024 - Present

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

  udemy

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

  April 2024 - Present

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

  udemy

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

  April 2024 - Present

• 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==

  April 2024 - Present

• Certified Quality Management System Lead Auditor

  TUV SUD

  June 2023 - Present

• 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==

  April 2023 - Present

• Medical Laboratory System and Internal Audit as per ISO xxxxxxxxxx

  Quality Council of India(QCI)

  June 2020 - Present

• Certificate in Biostatistics, Epidemiology and Research Methodology

  Manipal Academy of Higher Education

  January 2008 - Present