Expert in Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients
Expert ID: 727870 United Kingdom
installing (including EDX and WDX analysers), undertaking research and developing a range of test methods for both R&D and manufacturing facilities. Expert has worked in a range of industries
including food (forensic microscopist), energy (microscopist, EDX and WDX), nuclear (microscopist) and manufacture (spectrophotometry and electron microscopy). Work including developing
documentation for ISO 9001 certification and its maintenance.
Expert has spent the past 15 years working in Quality Assurance running ISO 9001, 14001 and 17025 quality systems in manufacturing (industrial, personal care, pharmaceuticals, tobacco
industries) and the past 4 in his own business successfully helping a range of different companies implement and maintain quality and environmental management systems.
Over the past 10 years Expert has been a successful auditor (internal and external) helping companies reduce operating costs, identify erroneous process flows and improve business.
Expert's business is a consulting business where he provides business consultancy to company's looking at improving their business processes
|Year: 1997||Degree: MSc||Subject: Environmental Analytical Chemistry||Institution: Birkbeck College|
|Year: 1985||Degree: BSc (HONS)||Subject: Biological Sciences||Institution: Plymouth Polytechnic|
|Years: 2008 to Present||Employer: Undisclosed||Title: Managing Director||Department:||Responsibilities: Expert Quality Solutions Ltd has been set-up to provide
• Consultancy services to companies (both Large and SME’s) who are either in need of complete QMS management or may require bespoke Quality services
• Auditing Services – this includes pharmaceutical suppliers and general quality
• Implementation of ISO quality systems
• Provision of Training Courses
Standards covered are ISO9001, ISO 9001 Exipact, ISO14001,ISO14064, ISO14065, ISO17020, ISO17025, Lexcel, GMP for Excipient manufacturers and verified Carbon Standard.
Work to date includes:
• Project managed implementation projects for companies seeking ISO 9001 certification
• Project managed implementation projects for companies seeking ISO 14001 certification
• Project managed implementation projects for companies seeking ISO 17020 accreditation
• Project managed implementation projects for companies seeking ISO 17025 accreditation
• Provision of GMP audits to pharmaceutical excipient manufacturers and their suppliers – this work included development of Gap Analysis reports that the auditee could provide to customers in lieu of 3rd party audits.
• Provision of ISO awareness training (ISO 9001, ISO 14001, ISO 17025)
• Provision of Training Courses (Uncertainty of Measurement, CAPA, Root Cause Analysis) – this has included a 10 year stint providing training to a gas company in Yemen and asbestos surveying company based in Kent
• Provision of desk assessments for applications to ISO14065 accreditation and Verified Carbon Standard Accreditation
• Involved with developing assessment methodology for a Korean standard based on ISO 14065 aimed at the validation and verification of Greenhouse Gas Reduction Projects
• Implementation of the Lexcel quality standard to local solicitors
|Years: 2006 to 2008||Employer: Arista Laboratories||Title: QS, EH&S and IT Manager||Department: Quality, IT and EH&S||Responsibilities: Arista Laboratories, Europe is one of a pair of laboratories providing a global speciality analytical service for the determination of analytes in tobacco and related products. I took on the dual role of QA Manager and H&S Manager 8 months after the previous incumbent had vacated the position through retirement. Over this period the laboratory had no direct QA or H&S support and had not replied to a February ISO 17025 re-assessment audit which almost resulted in a loss of accreditation and I managed to remedy within a month of starting at the company.
• Initiated operational changes which resulted in forecasted savings in excess of £120M for 2008
• Initiated changes in the quality system that resulted in improved awareness and adherence to quality standards
• In the first 3 weeks of taking the position I closed out all outstanding UKAS audit findings from the previous February to ensure continued accreditation
• Oversaw the successful transfer from ISO17025:1999 to ISO 17025:2005
• Increased the company’s Scope of Accreditation by >50%
• Project manager for successful implementation of LIMS to the laboratory
• Set up and run monthly training sessions to cover QA issues, H&S issues and team-building exercises
• Introduced a Management of Change system to the Kingston Laboratory
• Introduced a Permit to Work scheme for contractors at the Kingston laboratory to ensure that all new contractors receive a basic introduction to the site, their work plan is checked and they have a valid risk assessment for the work to be carried out
• Quality Manager for the Kingston-Upon-Thames laboratory
• Responsible for setting up and maintaining quality systems to ISO 17025 standard. This included:
• re-initiating a series of internal audits to cover all aspects of the laboratory’s quality system
• set up a system to track non-conformances ensuring their timely and effective completion
• provide all staff with training on document and record control
• responsible for initiating a programme of calibration and traceability for laboratory services
• Use of Minitab to set up SQC limits for all major analytes, data to be reviewed on a regular basis
• Review, revise and improve on all quality documents used at the Kingston site
• Health and Safety Manager for the Kingston-upon-Thames laboratory
• Responsible for undertaking Risk Assessments of all areas and processes with the Kingston site and develop improved control measures
• Responsible for undertaking CoSHH Risk Assessments for all chemicals used at the Kingston site and developing improved control measures
• IT Manager for the Kingston-upon-Thames laboratory
• Provide IT support to Kingston site. Liaise where necessary with remote consultant.
• UK Lead for team working on the implementation of a new LIMS into the Kingston site
|Years: 1999 to 2006||Employer: International Specialty Products Inc||Title: QA Compliance Specialist||Department: Quality||Responsibilities: QA Team Leader: June 2003 – December 2005
Senior Chemist, Customer Care: December 2000 – June 2003 Temporary Customer Care Specialist: September 1999 - December 2000
ISP is a global speciality chemicals manufacturer with over 4,000 employees worldwide. The company provides raw materials into a number of businesses including Pharmaceuticals, Personal Care, Food, Industrial and Household. I worked in all areas with the exception of food.
• Leader of a multi-disciplinary team across Europe responsible for the reduction of expired or deviated stock in Europe - reduced stock levels by over 50% ($700M) and made further savings of $1.3MM by reworking material in the 2005 calendar year.
• Set up a procedure to retest product before its expiry date to ensure that products are kept available in the marketplace to avoid the possibility of lost sales and build up of surplus stocks.
• Worked with QA manager to attain ISO 9001/2000 certification for European operation with an aim to complete project in 2006
• Audited external analytical company for compliance against ISP needs then worked alongside them to rectify all issues that were found ensuring continued business thereby saving ISP time and money in finding and qualifying a new supplier
• Following an internal audit became part of multidisciplinary team set-up to solve the issues found in the audit. The project took three months and improvements were made thereby reducing operational costs.
Responsibilities (QA Compliance Specialist):
• Certified GMP Excipient Auditor
• Qualified ISO 9001:2000 Lead Auditor
• Responsible for performing both external and internal audits on behalf of the European organisation in Europe and North America.
• Member of European Supply Chain team providing QA expertise and advice on distribution and repack issues.
• Following a complaint, work with the relevant production site ensure compliance to current procedures and that appropriate corrective and preventative actions are developed and put into action.
• Worked with Sales to ensure a timely response to complaints from key customers. Visit customers to discuss the issues and the actions taken to ensure the continuing supply of good quality material.
• Provided well-respected customer support for QA and technical enquiries. This was achieved either through direct liaison with the customer or through the Sales operation.
• Ensured European QA procedures are updated and relevant to the business.
• Undertook the supervision of up to 2 members of staff, responsible for their training and workload. Provide annual assessment.
• Liaised with upper management to ensure that the needs of the business are fully met.
• Liaised with regulatory team on initial REACH project
• QA responsibility for quality of material from the production sites. Discuss product developments, and ensure that plant procedures are followed to ensure the quality if the product.
• QA responsibility for warehousing of ISP products, providing the Supply Chain operation expert advice on quality-related matters including repack and rework operations. Also responsible for monitoring damaged stock in liaison with Supply Chain staff through regular visual inspections – making decisions on the saleability of material and ensuring viable products are released back into the marketplace to reduce operational costs and increase company profits.
• Administered the European part of a global computerised inventory system.
• Visited customer sites to resolve specific quality issues this has lead directly to saved business in excess of $1MM, either as the result of implementing changes of product quality at the production plant or convincing customers of the need for more analytical approach in their raw material evaluation.
• Discussed and agreed customer-specific quality agreements.
• Worked as part of multi-discipline team to develop new products to meet specific customer needs.
|Years: 1999 to 1999||Employer: British Nuclear Fuels||Title: Electron Microscopy Technician||Department:||Responsibilities: • Responsible for the general running of the SEM laboratory.
• Undertook analysis of materials using an Electroscan 2020 Environmental Scanning Electron Microscope (ESEM) equipped with an Oxford Instruments ISIS EDX
• Responsible for the maintenance of the ESEM, EDX and metallographical preparation equipment.
|Years: 1998 to 1999||Employer: Rank Hovis MacDougall technology||Title: Forensic Microscopist||Department:||Responsibilities: • Undertook forensic analysis of unknown components found in various foodstuffs involving the use ofimage processing software (Optimas and I Photo Plus), light microscopy, LEO VP435 Scanning Electron Microscope, Oxford Instruments ISIS EDX and FTIR.
• Created and set up a database of glass samples for use in forensic analysis using FTIR, image archiving software, and quantitative elemental analysis by EDX.
• Created and set-up a quality system for monitoring the efficiency of the departments forensic service.
|Years: 1997 to 1998||Employer: European Superconductor Supply Ltd||Title: Plant Chemist||Department:||Responsibilities: • Set up QA protocols for all incoming and outgoing materials.
• Set up and run analytical laboratory.
• Help set up and run production.
• Set up XRF laboratory.
• Responsible for the supervision of five members of staff.
• Provided first aid cover to the plant.
|Years: 1997 to 1997||Employer: International Specialty Products Inc||Title: Temporary Customer Care Specialist||Department:||Responsibilities: • Promptly responded to customer queries, provided the relevant sales team with all information required to satisfactorily conclude any complaint and ensured all samples reached the necessary analytical laboratory at the earliest opportunity to help minimise costs.
• Liaised with external laboratories to arrange for microbiological screening of indicated material.
• Administered a database to monitor the fate of all customer complaints.
• Created a database to monitor all microbiological screening analyses and subsequent data.
• Undertook trend analyses of customer complaints, and microbiological screening data to provide the management with the tools needed to maximise profit and minimise.
• Undertook analysis of complaint samples, as required using Malvern particle sizing, viscometry analysis (for K-value calculations), UV/VIS, Filter Flow Rate and Karl Fischer determinations. All major analyses were either shipped to an external laboratory or to the manufacturing plants for evaluation.
• Liaised with manufacturing plants and R&D department to arrange for the evaluation of customer complaints, as required.
• Liaised with Sales, Warehousing and Distribution staff and with external sampling agencies.
• Produced and maintained databases of customer complaints, microbiological screening data, external sampling etc., to monitor the progress of all work and to ensure a rapid turnaround
|Years: 1988 to 1997||Employer: Duracell Batteries Ltd||Title: Senior Development Scientist||Department: Analytical||Responsibilities: purposes and as a troubleshooting unit when there were problems found with either the product or the various processes involved in production.
• Undertook various development projects outlined by myself and / or the Analytical Services Manager to improve the working of the department.
• Set up and managed a well-equipped Scanning Electron Microscope laboratory, developed all methods and protocols relating to the analysis of battery materials. Responsible for purchasing equipment for the facility and for its validation.
• Managed an atomic spectroscopy laboratory (AA & ICP, equipped with graphite furnace and hydride generation capabilities). Responsible for the maintenance of the equipment and for developing methods to continually improve its use for QC work and for other scientist’s development projects. Responsible for the purchase and validation of equipment for the unit.
• Provision of training to other scientists (technicians to post-doctorate) in the use of various analytical techniques.
• Outsourced analyses to external laboratories when necessary and monitored their progress.
• Involved in large-scale multi-disciplinary projects, providing analytical support and advice
• Developed new analytical test methods and updated routine methods according to ISO9001.
|Associations / Societies|
|Royal Society of Chemistry
Institute of Biology
American Society of Quality
|Licenses / Certifications|
Certified Quality Auditor
|BSI review board for BS 89000|
Fields of Expertise
analytical data quality assurance, analytical electron microscopy, continuous quality improvement, electron microscope, electron microscopy, electron microscopy sample preparation, energy dispersive X-ray analysis, ISO 9000 auditing, ISO 9000 implementation, ISO 9000 quality system documentation, ISO 9000 registration system, ISO 9000 series quality system standard, ISO 9000 training, ISO 9001, manufacturing quality assurance, pharmaceutical manufacturing facility auditing, pharmaceutical quality assurance, pharmaceutical quality control, scanning electron microscope, scanning electron microscopy, SEM analysis sample preparation equipment, quality control, quality management, ISO 14001 Requirements with guidance for use, manufacturing quality control, 21 CFR Part 11, food manufacturing ISO quality management, Environmental Management System, ISO 14000 Environmental Management Standard, inductively-coupled plasma atomic emission spectroscopy, laboratory equipment, Current Good Manufacturing Practice, American Society for Quality Control, analytical chemistry instrument, British Standards Institution, atomic absorption spectrophotometer, TEM analysis sample preparation equipment, environmental scanning electron microscopy, British standard, industrial plant statistical quality control, environmental management, manufacturing documentation system, pharmaceutical industry, coating material quality assurance, chemical production quality management, pharmaceutical inventory management, statistical quality control, asbestos-related equipment, atomic absorption spectroscopy, packaging standard, calibration standard, optical microscopy, spectroscopy, pharmaceutical manufacturing, inductively coupled plasma spectrometry, Good Manufacturing Practice, analytical chemistry