Senior QA Specialist
|Contact Name:||John Reid|
My client a leading Pharmaceutical company now require a Senior QA Specialist
to join their rapidly expanding team.
The Senior QA Specialist is a key member of the Quality Assurance team associated with manufacturing of a new product 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
Requirements of Senior QA Specialist:
Primary Degree in a scientific discipline
Minimum of 5 years' experience in the pharmaceutical industry in a Quality role
Experience in solid oral dose manufacturing desirable but not a necessity
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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