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Principal Quality/GxP Auditor

Resource must have 10+ years of demonstrated experience in:

  •   FDA Law, Policies and Provisions specific to section 503B to the FD&C Act.

  •   Current Good Manufacturing Practices - Title 21 CFR Parts 210, 211, 820

  •   Execution of Current State GAP Assessment and FMEA activities

  •   Developing and driving risk based CAPA Plans & Remediation Efforts

  •   Consistently communicating/interacting directly with Health Authorities