Regulatory Compliance Specialist

hace 5 días


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

Company Overview

At Qrc Group Llc, we are committed to delivering exceptional regulatory compliance solutions to our clients. Our team of experts provides guidance and support in navigating the complex regulatory landscape, ensuring seamless operations and minimizing risks.

Job Description

We seek a highly experienced Regulatory Consultant to join our team. As a key member, you will be responsible for providing expert regulatory advice, preparing and reviewing regulatory submissions, assessing facility design, staying up-to-date with industry standards, and supporting CAPA plans.

Responsibilities
  • Provide strategic regulatory guidance for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.
  • Develop and review comprehensive regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
  • Evaluate and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
  • Stay current with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.


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