Profile Details

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USD 25 /hr

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Hire Saksham G.

India

USD 25 /hr

Pharmaceutical QA Consultant specializing in IPQA and cGMP compliance for global regulatory standards.

Profile Summary

Expert Quality Assurance consultant specializing in IPQA and cGMP documentation for the pharmaceutical industry. I bridge the gap between complex production cycles and strict regulatory compliance. My core expertise includes authoring and revising SOPs, Master Production Records (MPR), and Validation Protocols (IQ/OQ/PQ) with a focus on ALCOA+ Data Integrity. I help manufacturers eliminate documentation backlogs, streamline Batch Record Reviews, and conduct thorough Deviation & CAPA investigations to ensure "Right First Time" (RFT) metrics. Whether you need a remote auditor for mock-inspections or a technical writer for critical compliance documents, I provide the precision and regulatory foresight required to maintain 100% audit readiness and prevent costly product release delays.

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Pharmaceutical Manufacturing
• ☆ Public Health
• ☆ Healthcare Quality Improvement
• ☆ Quality Assurance & Quality Control (QA/QC)

Services

• Writing
• Research
• Product Development

Writing Non-Medical Regulatory Writing, Copywriting, General Proofreading & Editing

Research Gap Analysis

Product Development Product Validation, Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

Jr.Officer

Macleods Pharmaceuticals Ltd

January 2025 - Present

Education

Bachelor of Pharmacy (Gold Medallist)

Jiwaji University Gwalior

July 2018 - August 2022

Certifications

• Publication Certificate

  International journal of research publication and reviews

  September 2022 - Present