GMP Compliance Project Lead

hace 16 horas


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

About the Role:

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We are seeking an experienced GMP Compliance Project Lead to lead and manage projects in our aseptic areas

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The ideal candidate will have a strong background in project management, particularly in regulated pharmaceutical and medical device industries

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Responsibilities:

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  • ">
  • Develop project timelines, resource allocation plans, and budgets to ensure timely and on-budget delivery">
  • Coordinate and oversee all stages of project execution from design through to FDA submission">
  • Lead complex projects related to development, commissioning, process development, and validation of aseptic pharmaceutical or medical device products">
  • Ensure compliance with FDA and other regulatory bodies' requirements">
  • Prepare and review documentation for FDA submissions">
  • Work closely with internal stakeholders to ensure cross-functional alignment and timely execution of project milestones">
  • Manage risk assessments and mitigation strategies">
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Requirements:

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Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred)

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8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry

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Proven track record of leading projects through FDA submissions

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Strong knowledge of FDA regulations, aseptic processing, validation protocols, and good manufacturing practices (GMP)

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Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing

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What We Offer:

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A competitive salary and benefits package

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The opportunity to work on complex projects with a talented team

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Professional development opportunities



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