Qualified Person, Responsible Person and Quality Assurance
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Qualified Person services as per Directive 2001/83EC
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Interim QP services
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Quality improvement programmes based on Kaizen and tailored to company requirement
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Quality Systems implementation and compliance programmes (ISO9001:2000 or ICHQ10 (Pharmaceutical Quality System))
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Deployment of Risk Management (ICHQ9) and CAPA processes
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Act as Responsible Person as per GDP requirements (2013C/ 343/01).
Background & Case Studies
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Currently acting as Qualified Person for pharmaceutical companies covering solid dose and liquid dosages forms. Shortly, this will include veterinary products.
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Nominated as Head of QC on Mars's manufacturing authorisation at Birstall with responsibility for the site's QA activities.
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Established and later managed a Mars's pharmaceutical quality management system and internal audit programme.
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Successfully obtained marketing authorisations for a novel class of veterinary medicinal products which are still unique today.
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Implemented a tailored quality improvement programme based upon Kaizen, which increased levels of RFT (>95%) and decreased non-conformances by 80%.
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Deployed quality tools and techniques on numerous projects e.g. FMEA, root cause analysis and quality circles yielding both cost and quality benefits.
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Upgraded ISO 9000 quality system ensuring compliance with ICHQ10. Refined CAPA system from manual to computer based.
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Deployed as a Specialist in Plant on behalf of a major company so helping ensure the contract manufacturer met cGMP requirements.
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Acted as RP for Ascend Laboratories.
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Developed and implemented a Quality Management System for an pharmaceutical artwork systems provider. This was a hybrid system based upon elements of ISO9000 and ICHQ10.
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In 2017, assisted WDA holder company with a remediation programme. Later, attended a successful MHRA inspection which had minimal observations and positive comments regarding notable improvement in GDP compliance. CommQP had redesigned the QMS and provided a bespoke training programme.
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In 2018 & 2019, CommQP have assisted three clients in planning and setting up facilities & QMS for attaining MIA/ManA/WDA.
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Acting as QP for contract sterilisation services (gamma and e-beam) since 2018.
Qualification & Experience
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Permanent provision Qualified Person having successfully completed all QP training modules and associated exams.
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Held senior management positions in Quality Assurance with numerous years of experience in this field.
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Trained in Practical Problem Solving skills course.
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Upto date on CPD which is registered with the Royal Society of Chemistry.
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Relevant roles:
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Pharmaceutical Quality Manager at Mars Inc.
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Pharmaceutical Regulatory Affairs Manager at Mars Inc.
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Pharmaceutical Compliance Manager at Matthews Brand Solutions (senior management appointment)
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Group QA Manager at Matthews Brand Solutions (senior management appointment)
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Consultant Qualified Person at CommQP
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