My client a leading Pharmaceutical company now require a Qualified Person to join their expanding team.
The QP is a key member of the Quality Assurance team associated with sterile manufacture of an Advanced Therapeutic Medicinal Product. The Qualified Person (Biologics) may assume responsibilities in any work area of the Quality Department.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Qualified Person
- 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 (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 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 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.
- Acting as a designee to the QA Manager as required.
- Supervisory duties for Quality Assurance personnel may be part of the role
Requirements of Qualified Person:
- Primary Degree in a scientific discipline
- Must meet or undertaking 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 desirable.
- Experience of biologics manufacture is desirable.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below