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    Product Quality Engineer - New Haven, United States - PSG Global Solutions

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    Description
    We're looking for a

    Product Quality Engineer , working in

    Pharmaceuticals

    and

    Medical Products

    industry in

    100 College Street, New Haven, Connecticut, 06510, United States .


    Responsibilities:
    Develops the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation and Transfer
    Provides Quality oversight of the Design and Development Plan, User Requirement Specifications including Target Product Profile, Risk Management Plan, Design History File, and Design Review
    Maintains Product Quality Monographs, Supply Chain Maps, and Device Master Records in compliance with investigational product and commercial marketing applications
    Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters
    Provides lead quality review of CMC sections of Regulatory submissions and response to queries
    Owner of the stability program including ensuring annual commitments are met
    Manages reference standard program with a focus on ensuring supply
    Facilitates Product Specification Committee
    Facilitates global changes with respect to the product and design control
    Supports Health Authority inspections and compliance

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