Compliance Consultant

hace 1 día

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

Are you an experienced Compliance Consultant looking for a new challenge? We are seeking a professional with expertise in regulatory affairs and aseptic manufacturing to join our team at Qrc Group Llc.

Key responsibilities include:

  • Providing expert guidance on regulatory compliance for aseptic manufacturing processes.
  • Reviewing and preparing regulatory submissions to the FDA, ensuring accuracy and timeliness.
  • Collaborating with internal stakeholders to assess and advise on regulatory aspects of facility design.
  • Staying current with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Supporting the development and implementation of CAPA plans and responses to regulatory authorities.

Qualifications for this role include:

  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
  • Minimum 5 years of regulatory experience in the pharmaceutical or biotechnology industry, focusing on aseptic manufacturing and FDA submissions.
  • Strong knowledge of FDA regulations and aseptic processing guidelines.
  • Experience with FDA inspections and audits.

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