Quality Assurance Manager

Job title:

Quality Assurance Manager

Company

Cpl Group

Job description

Quality Assurance ManagerMy 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#LI-EG1

Expected salary

Location

Co Galway

Job date

Sun, 17 Nov 2024 04:17:41 GMT

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