Quality Assurance Manager for Third Party Operations
4 weeks ago
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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Morristown, Tennessee, United States Alvogen Full timeJob SummaryThe QA Manager Operations, Third Party supports Alvogen's commercial business by providing quality and compliance oversight of third-party contractors and external partners for distribution in the U.S. market.This position reports to the Associate Director, Operations of Third Party U.S. Quality and works closely with Supply Chain, Project...
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