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External Quality Assurance Expert
2 weeks ago
TN Ireland, a leading biopharmaceutical company based in Dublin, is seeking an External Quality Assurance Expert for our Contract Manufacturing oversight and quality systems. This role will support ongoing quality assurance responsibilities in support of drug substance, drug product, and finished product manufacturing.
Responsibilities:- Serve as Quality Assurance support and SME for Drug Substance, Drug Product, and Finished Product manufacturing, maintaining knowledge of industry standards and regulatory requirements to ensure compliance.
- Provide oversight of GMP systems completed by CMOs and External Supply Chain functions related to Drug Substance, Drug Product, and Finished Product.
- Support the development and implementation of continuous quality system improvements at CMOs in compliance, Preventive Maintenance, Deviation Management, and Change Control Programs.
In this role, you will collaborate with contract manufacturers' quality personnel and internal cross-functional impacted areas to resolve open issues in a timely manner resulting from record reviews and deviation events.
