Aseptic Area Project Coordinator

hace 2 días


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

Job Description:
A leading pharmaceutical company, Qrc Group LLC, is seeking an experienced Project Manager to lead and manage projects in aseptic areas. The ideal candidate will have a strong background in project management, with experience in the regulated pharmaceutical industry.

Responsibilities:
• Develop project timelines, resource allocation plans, and budgets for timely and on-budget delivery.
• Coordinate and oversee all stages of project execution from design through to FDA submission.
• Lead complex projects related to aseptic pharmaceutical product development and validation.
• Ensure compliance with FDA regulations, particularly in aseptic areas and sterile manufacturing processes.
• Prepare and review documentation for FDA submissions and other regulatory filings.

Requirements:
• Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
• 8+ years of experience in project management in a regulated pharmaceutical industry.
• PMP certified preferable.
• Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).



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