Lead Quality Analyst

Par Health

Not specified
Supplier quality oversight
Customer inquiry management
Audit coordination
Par Health is seeking a Lead Quality Analyst to oversee the Quality Assurance team, ensuring compliance with regulatory standards and enhancing supplier relationships. The ideal candidate will have extensive experience in pharmaceutical manufacturing and a strong understanding of quality systems

Job Summary

  • The Lead Quality Analyst acts as the team leader for Quality Associates and Analysts, serving as the primary for Annual Product Review, customer inquiries, gap assessments, customer audit coordination, and inspection readiness.
  • Essential functions include providing supplier quality oversight, managing customer inquiries, scheduling customer audits, and leading the Site Inspection Readiness Program.
  • The role requires a Bachelor’s degree in a scientific or technical field, a minimum of 10 years of technical experience in pharmaceutical manufacturing, and complete knowledge of FDA CFR and ICH guidelines.

Matching Summary

Match Score: 85

Par Health is seeking a Lead Quality Analyst to oversee the Quality Assurance team, ensuring compliance with regulatory standards and enhancing supplier relationships. The ideal candidate will have extensive experience in pharmaceutical manufacturing and a strong understanding of quality systems.

Skills & Requirements

Must-have

  • Supplier quality oversight
  • Customer inquiry management
  • Audit coordination
  • Inspection readiness program
  • SOP evaluation and approval
  • cGMP compliance

Nice-to-have

  • Continuous improvement culture
  • Teamwork and accountability
  • Elevating the essentials
  • Passion for improving lives

Key Requirements

  • Bachelor's degree in scientific/technical field
  • 10+ years pharmaceutical manufacturing experience
  • Knowledge of FDA CFR and ICH guidelines
  • Experience with cGMP, GLP, or GMP requirements

Work Rights

Not specified

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