Joan Benson Email & Phone Number

York, Gb

Lancaster, England, United Kingdom

Halton, Lancaster, Uk

Lead technical consultant for complex medical/aseptic/sterile facility guidance across all revenue streams, with special focus on Cleanroom project commissioning and qualification requirements Continuous development of depth and standard of C2C alignment to regulatory expectationsSupporting the maintenance and development of the Company Quality Management System Ensuring that all employees are trained and aware of the applicable regulatory standardsDevelopment of policy, and procedural documentation to facilitate consistent and repeatable performance to our clients and customers.Supporting the evolution of the QMS through audit, monitoring and control.Role model to the rest of the Organisation in behavioural standards and commitment to Quality and Health and SafetyProvision of consultative guidance to the Managing Director and the wider functional and business unit leadership teamsEnsuring effective Quality and H&S standards, processes and cultural expectations are promoted to all employees at all times

Manchester, United Kingdom

Management of the University of Manchester Cleanroom Facility including North West Embryonic Stem Cell CentreHead of Production for MHRA IMP and Specials licencesPerson Designate for HTA Human Application licenceSupervisor for EPSRC-MRC CDT in Regenerative MedicineMasterclass Lecturer for EPSRC-MRC CDT in Regenerative MedicineMasterclass Lecturer for Mres Tissue Engineering and Regenerative MedicineLead Auditor for GMP suppliersManagement of the Quality Management System

Liverpool, United Kingdom

Experience• GMP systems - design and support for IMP and Specials manufacture• Quality Management System - review, design and implementation• Quality Assurance and Quality Control - support for GMP• Experienced and qualified auditor - QMS auditor/Lead auditor for Pharmaceutical Industry• SOP - design, writing and review• Cleanroom - design and reviewExamples of consultancy work:• Design for cleanroom and Quality Management System for start up cell therapy company• Review of design for cleanroom to be used for build of ExoMars Rover (European Space Agency)• Lead Auditor for selection of contract manufacturing sites• Set up of full Quality Management and GMP systems for clinical research company in preparation for MHRA GMP licencing

Manchester, United Kingdom

Head of Production for MIA (IMP) and MS licencesManagement of the Production and Quality teams Principal point of contact for MHRA/other regulatory authoritiesProject management of Intercytex clinical trials Project management of Cell2Therapy studies contracted to IntercytexRegulatory preparation/review/submission Preparation/review/approval of GMP and GCP documentation Internal, supplier and importation auditOverall responsibility for H&S/COSHH/Risk Assessment

Manchester, United Kingdom

8 month secondment to special project management on recommendation of Executive VP Quality & Compliance and Corporate Training.

Manchester, United Kingdom

Head of Production for MIA (IMP) and Specials licencesPharmacy project management of client’s clinical trialsAudit of vendors, contractors and suppliers and review of suppliers for global supplier listSubject Matter Expert in GMPParticipation in regulatory inspections, client and internal audits for GMP and GCPLine management responsibility for technical and locum staffManagement of service contracts and validation processesPreparation and review of GMP documentation Responsibility for complaint, deviation and change control processesPreparation and review of H&S/COSHH data and risk assessments

Manchester, United Kingdom

Head of Production for MIA (IMP) and Specials licencesPharmacy project management of client’s clinical trialsSubject Matter Expert in GMPParticipation in regulatory inspections, client and internal audits for GMP and GCPLine management responsibility for technical and locum staffManagement of service contracts and validation processesPreparation and review of GMP documentation Responsibility for complaint, deviation and change control processesPreparation and review of H&S/COSHH data

(Ex Medeval), Manchester, United Kingdom

Head of Production for MIA (IMP) and Specials licencesPharmacy project management of client’s clinical trialsParticipation in regulatory inspections, client and internal audits for GMP and GCPLine management responsibility for technical and locum staffManagement of service contracts and validation processesPreparation and review of GMP documentation Preparation and review of H&S/COSHH data