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Develop 5-year
site strategy for Large UK based facility.
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Facility Design review for a
new large-scale biopharma and pharmaceutical sites.
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Developed the integrated timelines
from facility design to product
launch for a major $1 billion Start up.
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Developed and implemented site project management process.
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Transferred
a tabletting facility from Japan to Ireland.
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Developed the technology transfer management framework
to products from many sites overseas into one new
location.
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GMP
and regulatory compliance audits and system audits have been
performed for numerous facilities in Ireland, UK Europe and
Australia including pre-FDA audits.
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Compliance review of Automation for a large highly automated
facility.
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Managed the front-end design of a control system upgrade, which
involved the upgrade of the existing PLC and
batch
control systems
and the integration with the site ERP system.
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Downsized and turned around solid dose operations
for leading European Pharma Company.
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Rationalised solid dose manufacturing and packing operations of
major generic manufacturer doubling throughput
in the process
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Re-engineered topical cream & ointment sterile manufacturing
process to reduce the cycle time
from 16 hours to 8 hours
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Undertook process mapping on a medical device manufacturing
facility to convert existing process to cellular manufacturing and
eliminate NVA
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Undertook product development review of powder handling,
granulation and tabletting operations for a large multinational
solid dose manufacturing facility. The assignment included the
redesign of the powder handling and granulation processes with an
improvement process robustness that saved $1m annually.
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Designed and implemented a bar code data collection system to
automate inventory control and dispensing in a paste/tabletting
facility.
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Managed and implemented Irish site’s implementation of corporate
enterprise trading system that linked all site customers to 50+
customers globally. This involved the refining of processes on
site and the validation of the system to GAMP4
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Facilitated the development of all
Process Designs for an ERP implementation based on SAP.
