Quality Assurance Manager
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We are seeking a highly skilled Quality Assurance Manager to join our European Manufacturing and Distribution hub in county Galway.
This is an exciting opportunity for a seasoned professional to take on a leadership role within our quality team, driving continuous improvement and ensuring compliance with regulatory requirements.
Responsibilities:
* Lead the Quality Assurance team, including Qualified Persons, and ensure effective management of all batch disposition and material status control activities.
* Manage review of Batch Manufacturing Records (BMRs) and assist in investigations as part of the site Deviation Management System.
* Implement and manage the Change Control process, ensuring controlled implementation of all GMP related changes.
* Provide QA oversight of routine manufacturing, testing, and related activities to ensure ongoing cGMP compliance.
* Ensure effective participation of the Quality Assurance team in production and other site meetings.
* Develop and implement Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
* Participate in the site Internal Audit programme and external cGMP audits.
* Taking a leadership role in promoting a culture of Compliance, Right First Time, and Continuous Improvement.
Requirements:
* Primary Degree in Scientific discipline / Business / Supply Chain.
* A minimum of 10 years of experience in a Materials and/or production environment.
* ERP system experience.
* QMS experience, including ISO 13485 & 9001.
* Understanding of Lean/6 Sigma, ideally Green Belt or Black belt certified.
The successful candidate will be rewarded with a competitive salary of €80,000 - €100,000 per annum, depending on experience.