Regulatory Compliance Specialist

hace 2 días


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

Job Description

Company Overview: As a leading player in the pharmaceutical industry, Qrc Group, Llc strives to provide innovative solutions for complex challenges.

Job Summary: We are seeking a highly skilled Regulatory Consultant to join our team. The ideal candidate will have extensive experience in regulatory compliance, particularly in aseptic manufacturing environments.

Responsibilities:

  • Provide expert guidance on regulatory matters related to aseptic processing and pharmaceutical products.
  • Prepare and review submissions to regulatory authorities, ensuring timely and accurate documentation.
  • Evaluate and advise on facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
  • Stay up-to-date with FDA regulations and industry standards for aseptic processing.
  • Support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.

Requirements:

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


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