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 clients 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 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
- QMS experience
- ISO 13485 & 9001
- Understanding of Lean/6 Sigma is a must ideally Green Belt or Black belt certified.
For more information, please email [email protected]
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