My client a leading Pharmaceutical company now require a Lead Quality Assurance Specialist – Biologics to join their rapidly expanding team.
The Lead Quality Assurance Specialist – Biologics is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the site.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Lead Quality Assurance Specialist - Biologics
- Management of batch disposition and material status control activities
- Management of the Quality Assurance team in the production facility.
- 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
- Co-ordination of the Change Control process associated with production, ensuring controlled implementation of all GMP related changes
- QA oversight of routine manufacturing, testing and relating activities to ensure ongoing 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
- Motivation, training, discipline and appraisal of Quality Assurance staff.
- Acting as a designee to the Quality Assurance Manager as required.
Requirements of Lead Quality Assurance Specialist – Biologics:
- 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
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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