The Qualified Person (Cell Therapy) is a key member of the Quality Assurance team associated with sterile manufacturing.
Qualified Person: Pharmaceuticals: Dublin
The Qualified Person (Cell Therapy) is a key member of the Quality Assurance team associated with sterile manufacturing. The Qualified Person will assume the role of Qualified Person for the release of sterile product in accordance with EU Directive 2001/83/EC. In accordance with business needs, the Qualified Person may assume responsibilities in any work area of the Quality Department. As with all site personnel, the Qualified Person is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Cell Therapy Quality Department and across the site.
The responsibilities of the Qualified Person include the following:
- Management of batch disposition and material status control activities associated with Cell Therapy Products acting as a Qualified Person.
- 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 Cell Therapy 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.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of the company within the workplace.
- Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP reading, training and assessment.
Education and Experience:
- 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.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.