Qualified Person, Responsible Person and Quality Assurance

  • Qualified Person services as per Directive 2001/83EC

  • Interim QP services

  • Quality improvement programmes based on Kaizen and tailored to company requirement

  • Quality Systems implementation and compliance programmes (ISO9001:2000 or ICHQ10 (Pharmaceutical Quality System))

  • Deployment of Risk Management (ICHQ9) and CAPA processes

  • Act as Responsible Person as per GDP requirements (2013C/ 343/01).

Background & Case Studies

  • Currently acting as Qualified Person for pharmaceutical companies covering solid dose and liquid dosages forms.  Shortly, this will include veterinary products.

  • Nominated as Head of QC on Mars's manufacturing authorisation at Birstall with responsibility for the site's QA activities.

  • Established and later managed a Mars's pharmaceutical quality management system and internal audit programme.  

  • Successfully obtained marketing authorisations for a novel class of veterinary medicinal products which are still unique today.

  • Implemented a tailored quality improvement programme based upon Kaizen, which increased levels of RFT (>95%) and decreased non-conformances by 80%.

  • Deployed quality tools and techniques on numerous projects e.g. FMEA, root cause analysis and quality circles yielding both cost and quality benefits.

  • Upgraded ISO 9000 quality system ensuring compliance with ICHQ10. Refined CAPA system from manual to computer based.

  • Deployed as a Specialist in Plant on behalf of a major company so helping ensure the contract manufacturer met cGMP requirements.

  • Acted as RP for Ascend Laboratories. 

  • 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.

  • 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.

  • In 2018 & 2019, CommQP have assisted three clients in planning and setting up facilities & QMS for attaining MIA/ManA/WDA.

  • Acting as QP for contract sterilisation services (gamma and e-beam) since 2018.   

Qualification & Experience

  • Permanent provision Qualified Person having successfully completed all QP training modules and associated exams.

  • Held senior management positions in Quality Assurance with numerous years of experience in this field.

  • Trained in Practical Problem Solving skills course.

  • Upto date on CPD which is registered with the Royal Society of Chemistry.

  • Relevant roles:

    • Pharmaceutical Quality Manager at Mars Inc.

    • Pharmaceutical Regulatory Affairs Manager at Mars Inc.

    • Pharmaceutical Compliance Manager at Matthews Brand Solutions (senior management appointment)

    • Group QA Manager at Matthews Brand Solutions (senior management appointment)

    • Consultant Qualified Person at CommQP

Mukesh T Patel BSc(Hons) CChem MRSC CSci MCIPS
07831 398 653
mukesh.0001@yahoo.co.uk
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