Compliance Specialist

3 weeks ago


novato, United States Planet Pharma Full time
  • Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities
  • Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
  • Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
  • Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary
  • Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
  • Other duties as assigned

Requirements:

  • BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
  • Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
  • Excellent written, verbal, analytical, and interpersonal skills



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