Profile Details

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Hire Ruchira J.

India

USD 80 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ Pharmacy

Services

• 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)

Work Experience

Sr.Manager-GCP Quality

Nevakar India

May 2022 - Present

Manager-Clinical Quality

Abbot Helathcare

August 2016 - May 2022

Asst Manager- Clinical QA

Glenmark Pharmaceuticals Pvt.Ltd.

August 2011 - August 2016

Assiatant Manager- QA

Lambda Therapeutic Research Ltd

January 2005 - August 2011

Education

Bachelor in Pharmacy

KV College of Pharmacy

July 1994 - September 1998

Certifications

• Regiistered Quality Assurance Professional in Good Clinical Practice

  Society of Quality Assurance

  January 2023 - December 2025