Experience

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  Thames water

  Jan 1989 - Jan 1996

  Microbiologist

  Established Quality Control and Quality Management procedures for NAMAS (UKAS) accreditation

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  Vivendi

  May 1998 - Apr 2003

  Senior scientist

  Delivery of analytical results service to ensure compliance with requirements of the UK Drinking Water Inspectorate and UKAS. Managing the Vivendi Folkestone Laboratory and its Laboratory Quality System.

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  Aventis pharmaceuticals

  Apr 2003 - Jan 2005

  Microbiology analyst

  Routine environmental monitoring within sterile manufacturing facilities.Sterility Testing and method development.Training of QC and Manufacturing staff in aseptic processing.Validation/qualification of new methods and equipment, writing Standard Operating Procedures. Obtained Six Sigma Green Belt.

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  Sanofi

  Jan 2005 - Apr 2020

  Working to maintain and manage the site internal quality audit system. Performing quality audits and inspections to assure compliance with regulations. Reporting on progress and implementation of corrective and preventive actions.Analysing complex issues and processes and applying professional knowledge and experience to identify areas for improvement.Facilitating cross-functional teams to identify root causes and solutions to significant audit findings. Frequent inter-departmental contacts; building and proactively managing relationships with audited departments.Acting as source of quality expertise and advice for other functions.Monitoring schedule adherence and completion of corrective and preventive actions identified during internal quality audits. Reporting on status and key issues to the Quality Management Review and Site Quality CouncilPerforming auditor training and mentoring of trainee auditors on site.Facilitating a state of inspection readiness across the site. Participation in co-ordinating the provision of the backroom/frontroom for external and regulatory inspections. Show less Has extensive knowledge of manufacturing and related processes for sterile pharmaceutical products as a Quality Specialist and Auditor; detailed knowledge of EU, US and International regulatory requirements for manufacture and testing of pharmaceutical products and knowledge of auditing against cGMP and company standards. Plans and leads internal and external audits to assess compliance with regulations, guidelines, and operating procedures; prepare reports of findings to customers; provides consultation and advice to support management in promotion and assessment of compliance with regulations and guidelines. Evaluates policies and procedures for compliance with applicable regulations/guidelines and providing recommendations to management for continuous process improvements. Maintains the Company’s quality inspection and product release programs for materials and components, processes and finished goods. Gives due consideration for the application of environmental and health and safety standards. Communicates and maintains the site quality plan keeping our Quality Systems and Policies in compliance with Sanofi Corporate Global Quality Directives. Has good practical experience of change control management and regulatory compliance, ensuring compliance with cGMP regulations.Writes and provides consultation and advice for change control, CAPA, SOPs, master batch records, trend analysis, risk assessments, deviations, failure investigations, analytical and out of specification investigations.Prepares all Product Quality Reviews for Dagenham site. Provides quality support for significant product issues, in particular potential recalls and compliance issues. Provides training to Quality Officers and other key personnel on Quality Systems for new/transferred products and process changes.Tim’s experience and knowledge continues to be sought externally to assist in preparation for regulatory inspections and as an industry expert in aseptic processing. Show less • Introducing the Eloxatin dosage form to Dagenham site with Industrial Development team including all process validation, cleaning validation and preparation of documentation and reports for regulatory submission. Providing continuing technical support and expertise for issues related to production of Eloxatin.• Supporting Production in areas relating to manufacturing and filling of sterile products and developing a close working relationship with Production and Quality departments. Worked to improve performance and consistency of sterile filter integrity testing.• Ensuring the successful production of clinical trials batches including preparation of all documentation and all quality aspects of critical raw materials and key components.• Worked with CMOs to develop filling processes for existing sterile oncology products. Show less

  • Quality Auditor

    Oct 2012 - Apr 2020

  • Pharmaceutical Quality Specialist

    Nov 2008 - Oct 2012

  • Process Technologist

    Jan 2005 - Nov 2008
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  Achilles therapeutics limited

  Apr 2020 - Dec 2022

  Senior manager

  Achilles Therapeutics is a biopharmaceutical company developing personalised T cell therapies targeting neoantigens: protein markers unique to each individual that are present on the surface of a cancer cell and can be detected by the immune system. Our approach is based on the science of tumour evolution which allows us to identify neoantigens that arise early in the cancer’s development and are retained as each tumour grows. These ‘clonal’ neoantigens are present on all the cancer cells and are completely absent from a patient’s healthy tissue. By directing T cells therapies to clonal neoantigens we can for the first time target every cancer cell without attacking healthy tissue.My role within Achilles was primarily that of maintaining Quality Systems and the introduction of the Veeva eQMS. Show less

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  Thb quality ltd

  May 2024 - now

  Director, senior auditor and gmp consultant

  THB Quality Ltd provides GMP Consultancy and Auditing services to the Pharmaceutical Industry. I am an experienced auditor with excellent attention to detail; I am also a committed trainer within the GMP environment. I can deliver GMP refresher training to large audiences without a problem. I have an excellent working knowledge of GMP regulations and experience installing electronic QMS systems and developing Quality Management Systems and the associated culture needed to achieve excellence. With the success being achieved I will be looking to employ like-minded people very shortly. Show less

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  Caroline coastal fm

  Jun 2024 - now

  Radio presenter

  My transition to broadcasting is a testament to my adaptability and dedication to delivering quality entertainment and information. At Caroline Coastal, I curate playlists that resonate with diverse audiences, blending classic hits with contemporary tunes. My commitment to excellence continues to thrive, as I focus on creating memorable experiences for listeners while exploring opportunities to expand our reach and impact within the vibrant field of radio.Caroline Coastal is a radio station that provides a 24-hour daily radio service for the towns and villages within the Maldon and Burnham District on the Essex coast on 94.7 and 104.7FM. Our programmes are also available on smart speakers, various apps and carolinecoastal.co.uk Show less