Responsible for managing the Quality Assurance team associated with production of a Cell Therapy product
Quality Assurance Executive- Pharmaceuticals-Dublin
The Quality Assurance Executive is responsible for managing the Quality Assurance team associated with production of a Cell Therapy product. In accordance with business needs, the Quality Assurance Executive may assume responsibilities in any other work area of the Cell Therapy Quality Department. As with all site personnel, the Quality Assurance Executive is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Cell Therapy Quality Department and across the site.
- Management of the Quality Assurance team in the Cell Therapy manufacturing facility.
- Management of batch disposition and material status control activities associated with the product
- 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 Cell Therapy 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 Department 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 Quality Assurance Manager as required.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values 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.
- Other duties as required and directed by the relevant Manager
EDUCATION AND EXPERIENCE:
- Primary Degree in a scientific discipline
- Minimum of 5 years' experience in the pharmaceutical industry in a Quality role.
- Experience of in the manufacture Biologics and aseptic manufacturing
- Cell Therapy (ATMPs) would be advantageous
- Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for aseptic manufacturing, ATMP and Biologic.
- High level of initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
- People management experience is desirable but not essential.
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.