Managing FDA Quality / Compliance Consultant

Title:      Managing FDA Quality/Compliance Consultant

Type:    Full Time Employee

Position Information:                

Senior Quality Assurance/Compliance strategist with 20+ years of experience across regulated product classes including pharmaceuticals, medical devices and biologics. Ability to work with clients to develop quality, compliance and regulatory strategies for compliance with FDA requirements and expectations. Demonstrated accomplishments in:

  • Quality systems assessment – design control, systems development and implementation, ISO 13485/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR)
  • Quality control, assurance and management
  • Validation programs – analytical method/cleaning/equipment/process
  • CAPA/non-conformance investigations/root cause analysis
  • Batch record review
  • SOP development
  • Vigilance and post-market surveillance
  • Warning Letter responses and planning and FDA-483 responses
  • Adverse Event Evaluation and recalls
  • Complaint handling and MDRs
  • Audits for Certification/Due Diligence/cGMP (Pharmaceutical), PAI audits
  • Hazard and Risk Analysis: ISO – 14971
  • PAI Audits
  • Good documentation practices

Preferred Education:                  

Degree in engineering, pharmacy, bioengineering, medical technology, biology, chemistry or related technical discipline required.

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