We are looking for GMP Compliance / Validation Specialist to work on an AI-based project of our client.
Project: US Pharma
Experience: 5+ years in GMP audits, process validation, equipment qualification, change control
Pay: $15 - $25 (Based on Experience and Profile)
Number of hours: Minimum 4-5hours/day
Duration- 2-3 days(can be extended)
Skills: Mandatory to have US Pharma experience
Project Start Date: Immediate
Role Overview:The project aims to evaluate dataset accuracy across three dimensions—prompts, rubrics, and artifacts—with a focus on scientific and regulatory correctness, source-document consistency, and benchmark quality.
Education Background: Bachelor's or Master's in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Chemical Engineering, or related fields.
PharmD or PhD preferred for specialized roles.
Required Skills
Regulatory knowledge: Working knowledge of FDA 21 CFR Parts 210/211, ICH Q7–Q12, GMP, and applicable FDA/EMA guidance
Documentation expertise: Experience with SOPs, specifications, batch records, deviation reports, CAPA, change controls, or CTD Module 3.
Evaluation skills: Robust written English and ability to assess AI-generated responses against detailed rubrics.
Analytical skills: Ability to reconcile conflicting records, identify authoritative documents, and provide evidence-backed decisions.
📌 US Pharma-GMP Compliance / Validation Specialist (India)
🏢 EduRun Group
📍 India
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