Company:
PSG Global Solutions
Location: New Haven
Closing Date: 20/10/2024
Salary: £100 - £125 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / 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.
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