Senior Quality Specialist
|Contact Name:||John Reid|
My client a leading Pharmaceutical company now require a Senior QA Specialist
to join their expanding team.
The Senior QA Specialist is a key member of the Quality Assurance team associated with production of solid oral dosage product due for commercial production within the next 12 months.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Senior QA Specialist
Management of batch disposition and material status control activities
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.
Acting as a designee to the Quality Executive as required.
Requirements of Senior QA Specialist:
Primary Degree in a scientific discipline
Must meet now or plan to within the next year 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 solid oral dosage manufacture.
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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