Aseptic Manufacturing Expert

hace 1 día


San Juan, San Juan, Puerto Rico Qrc Group, Llc A tiempo completo

Job Description

The Qrc Group, Llc seeks a seasoned professional to provide expert regulatory guidance and support in navigating the aseptic production environment. As an Aseptic Manufacturing Expert, you will play a critical role in ensuring compliance with FDA and global regulatory standards.

Responsibilities:

  • Provide expert regulatory advice for aseptic manufacturing processes.
  • Prepare and review regulatory submissions to the FDA.
  • Assess and advise on the regulatory aspects of facility design.
  • Stay up-to-date with FDA regulations and industry standards for aseptic processing.
  • Support the preparation and submission of CAPA plans and responses to regulatory authorities.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
  • 5+ years of regulatory experience within the pharmaceutical or biotechnology industry.
  • Strong understanding of FDA regulations and aseptic processing guidelines.
  • Experience in preparing for and supporting FDA inspections and audits.


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