Qualified Person - Dublin.
In this role you will act as a key member of the Quality Assurance team associated with sterile manufacture of an Advanced Therapeutic Medicinal Product (ATMP).
In particular, as Qualified Person (ATMP) you will assume the role of Qualified Person for the release of ATMP in accordance with EU Directive 2001/83/EC.
In addition, a with all site personnel, the Qualified Person (ATMP) is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the site.
• Management of batch disposition and material status control activities associated with Advanced Therapeutic Medicinal Product acting as a Qualified Person.
• Management of review of Batch Manufacturing Records (BMR's).
• Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPA's.
• Management of the Change Control process associated with ATMP manufacture and testing, ensuring controlled implementation of all GMP changes.
• QA oversight of routine manufacturing, testing and relating activities to ensure on-going 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.
• Acting as a designee to the QA Manager as required.
• Supervisory duties for Quality Assurance personnel may be part of the role.
Interested applicants should have:
• Primary Degree in a scientific discipline
• Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
• Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
• Experience of sterile manufacture is essential.
• Experience of biologics manufacture is desirable.
• Excellent knowledge of Good Manufacturing Practice for Advanced Therapeutic Medical Product (ATPM).
• High level of initiative.
• Excellent verbal and written communication skills.
• Strong project management and organisational skills.
• Ability to adapt to changing priorities.