Pharmaceutical Quality SME

Baltimore, MD

Job ID: 128456 Industry: Pharma

Quality GCP Specialist 

Project Description:

Our client is a global bio-pharmaceutical company in late Phase 3 development. They are looking for a GCP Specialist to support their clinical QA team. 

Day to Day Responsibilities:

Our client is looking for a Director Level Quality Specialist to support the development of a phase 3 API drug product. This person should come from a Quality Systems and Quality Compliance background. They will be reviewing all types of protocols, and reviewing and writing GCPs. They will also be responsible for managing and executing audits, both  on-site and at clinical investigator sites. They should have experience writing investigator brochures.  This person should be a SME in GxP regulations. The ideal candidate will have excellent communication skills. 

Required
  • Quality Compliance
  • Quality Systems
  • Audit Execution
  • GxP Regulations 
  • Pharmaceuticals

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