プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Nelson B.に依頼

India

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

プロフィール概要

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.

専門分野

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

サービス

• Writing
• Research
• Product Development

Writing Medical Writing, Technical Writing

Research Gap Analysis

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

職務経験

Team Leader

Onesource CDMO

7月 2021 - 現在

Senior Validation Engineer

Zydus Biologics

5月 2018 - 6月 2021

Senior executive

Panacea Biotec

12月 2015 - 4月 2018

Senior QA-Operations

Meji medreich

4月 2015 - 12月 2015

executive

Biocon

4月 2010 - 7月 2012

学歴

M.Sc.Biotechnology

Bangalore University

7月 2012 - 1月 2024

Chemistry

Andhra university

7月 2007 - 6月 2010

認定資格

• Validation and Qualification for Pharma, Biotech and Food Industries

  Alison

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

  7月 2025 - 現在