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Product Quality Engineer

Company: PSG Global Solutions
Location: New Haven
Posted on: January 19, 2023

Job Description:

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

Keywords: PSG Global Solutions, New Haven , Product Quality Engineer, Engineering , New Haven, Connecticut

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