Overview:
The Senior Quality Specialist is an expert in their assigned area and has a strong understanding of current FDA, EU and ICH requirements. This role may specialize in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements.
This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed and released within the specified timeframes. Ability to…
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