Pharmaceutical Compliance Advisor

hace 6 días


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

**Regulatory Consultant Job Description**

At Qrc Group Llc, we are committed to delivering high-quality products while maintaining the highest level of regulatory compliance. To achieve this goal, we are seeking an experienced Regulatory Consultant to join our team.

The ideal candidate will have a strong understanding of FDA regulations and industry standards for aseptic processing and pharmaceutical products. They will be responsible for providing expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.

In addition to providing expert regulatory advice, they will be responsible for preparing and reviewing regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.

They will also assess and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.

**Responsibilities:**

  • Ensure compliance with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Develop and implement regulatory strategies to ensure alignment with company goals.
  • Prepare and review regulatory submissions to the FDA, ensuring timely and accurate submission of required documents.
  • Collaborate with cross-functional teams to ensure alignment on regulatory requirements.

**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, 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.


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

    Company OverviewAt 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 DescriptionWe seek a highly experienced Regulatory Consultant to join our team. As...


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

    **Job Description for Regulatory Consultant at Qrc Group Llc**We are seeking an experienced Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.The ideal candidate will have strong understanding of FDA regulations and aseptic processing guidelines. They will be...


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

    Job Title: ASEptic Manufacturing ExpertReports to: Director of Regulatory AffairsAt Qrc Group Llc, we are committed to delivering exceptional regulatory compliance solutions to our clients. We seek a highly experienced ASEptic Manufacturing Expert to join our team. As a key member, you will be responsible for providing expert regulatory advice, preparing and...


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

    Job SummaryQrc Group Llc is seeking a seasoned Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments. The successful candidate will be responsible for providing strategic regulatory advice, developing and reviewing regulatory submissions, evaluating facility...


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

    Digital Quality Manager RoleWe are looking for a highly skilled Digital Quality Manager to lead projects focused on the implementation of digital and AI solutions that drive process performance and enhance operational excellence.The successful candidate will have experience in regulated industries, with a strong understanding of data integrity compliance and...


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

    Project Management ProfessionalWe are seeking a highly skilled Project Management Professional to lead projects focused on the implementation of digital and AI solutions that drive process performance and enhance operational excellence.The successful candidate will have experience in regulated industries, with a strong understanding of data integrity...


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

    QA Project LeadWe are seeking a highly skilled QA Project Lead to oversee projects focused on the implementation of digital and AI solutions that drive process performance and enhance operational excellence.The ideal candidate will have experience in regulated industries, with a strong understanding of data integrity compliance and Good Manufacturing...


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

    **Qrc Group Llc Seeks Experienced Regulatory Consultant**We are looking for a highly skilled Regulatory Consultant to join our team at Qrc Group Llc. As a key member of our team, you will play a critical role in ensuring that our company remains compliant with FDA regulations and industry standards.Your primary responsibility will be to provide expert...


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

    QC Project Manager Opportunity">We are seeking a highly skilled QC Project Manager to join our team in the regulated industry.">Duties and Responsibilities:Manage projects related to laboratory testing, method validation, and equipment qualification to ensure timely release of materials and products.Coordinate projects aimed at improving laboratory...


  • San Lorenzo, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Role OverviewFlexible & Integrated Technical Services, LLC is looking for an EHS Professional to support our projects in the Manufacturing area. As an EHS Professional, you will ensure compliance with national statutory health and safety requirements and develop performance metrics to measure our success.RequirementsBachelor's Degree in Science with 4+ years...

  • EHS Professional

    hace 5 días


    San Lorenzo, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    About the RoleFlexible & Integrated Technical Services, LLC is seeking an EHS Professional to provide program-level governance support for various projects in the Manufacturing area. This role will be responsible for developing and presenting performance metrics, delivering safety presentations, and ensuring compliance with national statutory health and...


  • San Lorenzo, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job SummaryFlexible & Integrated Technical Services, LLC is seeking an EHS Professional to join our team. In this role, you will provide program-level governance support for various projects in the Manufacturing area, ensuring compliance with national statutory health and safety requirements.Key RequirementsBachelor's Degree in Science with 4+ years of...