プロフィール詳細

プロジェクトを作成

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Ruchira J.に依頼

India

Freelance Good Clinical Practice Quality Professional with 20 years of Global Audit experience, QMS

プロフィール概要

My expertise spans Phase I–IV and BA/BE trials across diverse therapeutic areas, with a proven track record in GCP,CGLP,and Preclinical. I have led global audits of investigator sites, preclinical facilities, clinical laboratories, and trial supply vendors across the US, Europe, and Asia. Known for driving inspection readiness, TMF remediation, vendor oversight, and compliance strategies—resulting in 100% site compliance and multiple successful USFDA inspections with zero findings. Now seeking to leverage this expertise in a consulting capacity to support sponsors, CROs, and trial sites in achieving inspection readiness and operational excellence.

専門分野

• ☆ Pharmacy

サービス

• Writing
• Research
• Product Development

Writing Clinical Trial Documentation, General Proofreading & Editing

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

Product Development Quality Assurance & Control (QA/QC)

職務経験

Sr.Manager-GCP Quality

Nevakar India

5月 2022 - 現在

Manager-Clinical Quality

Abbot Helathcare

8月 2016 - 5月 2022

Asst Manager- Clinical QA

Glenmark Pharmaceuticals Pvt.Ltd.

8月 2011 - 8月 2016

Assiatant Manager- QA

Lambda Therapeutic Research Ltd

1月 2005 - 8月 2011

学歴

Bachelor in Pharmacy

KV College of Pharmacy

7月 1994 - 9月 1998

認定資格

• Regiistered Quality Assurance Professional in Good Clinical Practice

  Society of Quality Assurance

  1月 2023 - 12月 2025