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 Quality System Improvement
As a Qualified Person for over 25
years and a Quality Manager for a
similar period I am fully familiar with
Quality System design and
improvement.
I also offer Quality
System gap analysis and am well
placed to assist with SOP
development. I have worked with
both Manufacturing and Research
and Development systems and have
experience of major Regulatory
Authority requirements. ISO9000
systems are also familiar to me.
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 Organisational Improvement
After over 35 years experience in the
pharmaceutical industry I have
developed a business-driven focus to
organisational development.
Simplification and standardisation are
key elements in the approach. I have
reorganised both Quality and Supply
Chain organisations and I also have
Research and Development
experience.
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 Auditing
I am a trained ISO9000 and GXP
Auditor and have undertaken many
audits during my 35 year plus career.
I have carried out Due Diligence
audits; For Cause audits; Corporate
style audits; Manufacturing Site
audits; API QP certification audits;
Excipient audits; Packaging material
audits; Contract Laboratory audits;
and Research and Development Site
audits.
I offer a professional service
including audit preparation and audit
reporting.
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 Audit Preparation
During my 35 year career in the
industry I have led site teams in
preparation and undertaking of audits
from FDA; MHRA; Japanese Health
Authority; Major Pharmaceutical
Companies; Corporate Compliance;
BSI etc.
I am experienced in audit
response preparation and am well
placed to prepare personnel (audit
guides; auditees; subject matter
experts) for audit roles.
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 Training
I have experience in Research and
Development; Supply Chain; and
Quality organisations within both
branded pharmaceutical
manufacturing and contract
manufacturing.
I can provide tailor
made training to meet the needs of
your organisation - GMP; SOP;
Auditing; Process; etc.
I am also well placed to act as a mentor to QPs and
Quality Managers or Engineers in your
organisation.
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 Contract QP Services
I have been a Qualified Person under
the transitional arrangements since
1984. I am prepared to offer cover for
holiday, illness or other absence of
your regular QPs.
Please note that I
do not cover Investigational Medicinal
Products. With 25 years experience
as a QP I have experience in the
following dosage forms - Tablets;
Capsules; Liquids; Creams;
Transdermal products; Medicinal
Aerosol products.
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qpvision.co.uk
Phone/Fax : +44 (0)7590 927528