Quality Assurance Manager
We are seeking a highly skilled Quality Assurance Manager to join our team at an international manufacturer of health and wellness products. The successful candidate will be based in our European Manufacturing and Distribution hub in County Galway.
This is an exciting opportunity for someone who has experience in managing quality assurance teams, with a clear progression path to 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 relating 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 Chain
* Years of experience: 10
* Experience: Materials and or production environment essential
* ERP system knowledge
* QMS experience
* ISO 13485 & 9001 knowledge
* Understanding of Lean/6 Sigma is a must ideally Green Belt or Black belt certified.
The estimated salary for this position is £60,000 - £80,000 per annum depending on experience.