Quality Auditor GxP (v534)

  • Contract Duration: 6+ months, potential to extend
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to fill a contractual role for a Quality Auditor with one of our global pharmaceutical clients. This is a six-month contract with the possibility of extension based on need and performance.

Key Duties and Responsibilities of a Quality Auditor:

  • Coordinates the development of, maintains, supports activities for, and executes audit plans
  • Provides input for audits that are outsourced
  • Conducts audits of GMPs or GDPs for CxOs
  • Engages in preparation, support, and follow-up activities for inspection readiness
  • Provides regulatory compliance support to cross-functional teams as requested
  • Serves as GxP quality management system resource
  • Participates in collaborative review of impacted SOP/WI
  • Analyzes risk and proposes remedial, corrective, and/or preventive actions
  • Provides cross-functional support across the QA team

Knowledge and Skills of a Quality Auditor:

  • Thorough/broad knowledge of:
  • GMP and/or GDP audit processes
  • GMP and or GDP quality systems
  • Regional/international knowledge of GxP regulations
  • CMC documentation
  • Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
  • Change management and risk management principles and process knowledge

Education and Experience of a Quality Auditor:

  • Bachelor’s degree in a relevant field is required
  • Typically requires 4 years of experience or the equivalent combination of education and experience
  • Experience as GxP generalist or in applicable specialty area such as manufacturing, distribution, laboratory, or clinical practices
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– The Lenox Executive Search Team