Pharmaceutical Quality PAI Specialist

Charlotte, NC

Job ID: 128034 Industry: Pharma

Pharmaceutical Quality PAI Specialist

Environment

Our client is a large pharmaceutical company with a new API controlled substance in the pre-approval stages. They are seeking a Quality Specialist to oversee one of their CMO sites in order to ensure PAI readiness.

Background

This person will be providing Quality auditing oversite at a CMO facility that is producing an active pharmaceutical ingredient. This individual must be a PAI readiness expert. This person must come from a quality compliance and API chemistry background, and should have a strong understanding of quality systems as it relates to process validation. The goal of this position is to ensure the CMO site will be inspection ready for scheduled visit from the FDA. Strong communication skills are required. 

Required
  • API - Chemistry Background
  • Quality Compliance (10+ years)
  • PAI Readiness Expert 
  • Controlled Substances 

Job Type: Contract  

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