Quality Assurance Manager My client, an international manufacturer of health and wellness products, is looking to recruit a Quality Assurance Manager. The Quality Assurance Manager will work in the client's European Manufacturing and Distribution hub in county Galway. Over the past 5 years, the client has gone through considerable growth, and it is due to this growth and expansion that they are looking to recruit a Quality Assurance Manager. There will be a clear progression path for the successful candidate to eventually go into a director role if desired.
Responsibilities: Management of the Quality Assurance team, including Qualified Persons.Management of all batch disposition and material status control activities.Management of review of Batch Manufacturing Records (BMRs).Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.Management of the Change Control process, ensuring controlled implementation of all GMP related changes.Management of QA oversight of routine manufacturing, testing and related activities to ensure ongoing cGMP compliance.Ensuring effective participation of the Quality Assurance team in production and other site meetings.Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.Participation in the site Internal Audit programme.Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.Communication and liaison with other departments on Quality issues (as required), providing guidance and support to others.Motivation, training, discipline and appraisal of Quality Assurance staff.Acting as a designee to the Site Quality Head as required.Requirements: Qualification: Primary Degree in Scientific discipline / Business / Supply ChainYears of experience: 10Experience: Materials and or production environment essentialERP systemQMS experienceISO 13485 & 9001Understanding of Lean/6 Sigma is a must ideally Green Belt or Black belt certified.
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