Quality Assurance Manager for Third Party Operations

4 weeks ago


Morristown, Tennessee, United States Alvogen Full time
Job Summary

The Quality Assurance Manager for Third Party Operations will provide quality and compliance oversight of third party contractors and external partners for Alvogen Inc. for distribution in the U.S. market.

Key Responsibilities

Handles day-to-day Quality responsibilities for assigned products manufactured by Third party suppliers and distributed by Alvogen in the US
Performs batch record review and release for Third party manufactured products
Reviews and approves Deviations, Investigations and Change Controls associated with Third party manufactured products
Tracks metrics for external businesses partners/CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third party QA KPIs (Key Performance Indicator)

Requirements

Bachelor's degree in Chemistry, General Biological/Physical Science or related science from an accredited college or university
Minimum of 10 years of experience in Quality in the pharmaceutical industry
Previous experience with Third party / supplier Quality
Strong knowledge of cGMP and US FDA regulations

What We Offer

Opportunity to work with a leading pharmaceutical company
Collaborative and dynamic work environment
Competitive salary and benefits package

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