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The Quality Assurance Executive (API) is responsible for managing the Quality Assurance team associated with production of oral solid dosage product in the P1 (API) production facility at Takeda Ireland Limited Grange Castle (TILGC).
In accordance with business needs, the Quality Assurance Executive (API) may assume responsibilities in any other work area of the TILGC Quality Department.
The responsibilities of the Quality Assurance Executive (API) include the following:
• Management of the Quality Assurance team in the API production facility.
• Management of batch disposition and material status control activities associated with API.
• 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 associated with API, 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 API Quality Assurance team in production and other site meetings.
• Implementation of Key Performance Indicators within the API 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 TILGC 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 Quality Assurance Manager as required.