Profile Details

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Hire Nelson B.

India

USD 40 /hr

Pharmaceutical QA & Validation Expert | CSV, Equipment Qualification, and GxP Compliance Specialist

Profile Summary

I am a Pharmaceutical QA and Validation Specialist with over 12 years of experience in Computer System Validation (CSV), Equipment Qualification (IQ/OQ/PQ), and GxP Compliance within regulated environments. My expertise covers Quality Management Systems (QMS), risk-based validation approaches, and audit-ready documentation aligned with GMP, FDA, and EMA guidelines. I support pharma and biotech companies in achieving and maintaining regulatory compliance by providing expert guidance in validation strategy, documentation review, SOP preparation, and process optimization. My approach is structured, data-driven, and aligned with industry standards, ensuring smooth inspections and successful audits.

Subject Matter Expertise

• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Biologic & Biosimilar Manufacturing

Services

• Writing
• Research
• Product Development

Writing Medical Writing, Technical Writing

Research Gap Analysis

Product Development Recipe Development, Manufacturing, Quality Assurance & Control (QA/QC)

Work Experience

Team Leader

Onesource CDMO

July 2021 - Present

Senior Validation Engineer

Zydus Biologics

May 2018 - June 2021

Senior executive

Panacea Biotec

December 2015 - April 2018

Senior QA-Operations

Meji medreich

April 2015 - December 2015

executive

Biocon

April 2010 - July 2012

Education

M.Sc.Biotechnology

Bangalore University

July 2012 - January 2024

Chemistry

Andhra university

July 2007 - June 2010

Certifications

• Validation and Qualification for Pharma, Biotech and Food Industries

  Alison

  https://alison.com/certification/check/9da073f92f

  July 2025 - Present