Jonathan Rees Email & Phone Number

Global Quality Management System ConsultantMedical Devices/Pharmaceuticals/In-Vitro DiagnosticsQMS Implementation & Remediation ExpertSupplier Quality Management/Purchasing Controls SpecialistExternal Lead Auditor (ISO9001/ISO13485/ISO17025)Equipment/Method Validation (URS/DQ/IQ/OQ/PQ)NC/CAPA/SCAR Process ImprovementsRegulatory Audit PreparationCustomer.

Raynham, MA, US

Providing process validation support in development of test method validation processes and procedures. Contributing consultancy support to global project to review, revise and implement validation process improvement across multiple sites.

Saint Paul, Minnesota, US

Abingdon, GB, GB

Proving part time, ad hoc QA Management support to develop QMS and maintain ISO13485 certification.

Waltham, MA, US

Provide part time, ad hoc QMS support on Trackwise to review, feedback and approve records.

Marlborough, Massachusetts, US

Provide general consultancy support in matters related to Quality Assurance for aseptic sterile manufacture of injectable pharmaceutical products. Support to include assistance with Quality Events, Non-Conformances, Root Cause investigations, CAPA, Change Control, Validation (URS/IQ/OQ/PQ) and OOS/OOT investigations.

Dublin, Coolock, IE

Lead/support the EUMDR Hazardous Substances implementation project. Lead global supplier qualifications and change notifications for new suppliers, new materials, or changes to existing suppliers or materials. Own Site record (ASL) for global suppliers ensure compliance with client policies and procedures.

Chepstow, Monmouthshire, GB

Providing broad Quality Engineering R&D support to ensure compliant delivery to market of novel medical devices. Ensure product streams complete phase requirements (Definition, Design & Development, Verification & Validation) then ultimately before transfer to Manufacture. Review and approval of documentation requirements as listed in product Technical.

Marlborough, MA, US

Integration of new business acquisition suppliers into international approved supplier list. Analysis of legacy suppliers to include identification of gaps, generation of action plan, closure of identified gaps. Main responsibilities include Supplier Set-up and Risk Assessment, coordination of Quality Agreements, planning and execution of Supplier Audits.

Warsaw, Indiana, US

Project manage implementation of new Unique Device Identifier (UDI) regulations at site as required by the FDA. Identification of products and suppliers within scope. Communication of requirements to suppliers and coordination of required activities to provide evidence of compliance. Guidance, review and approval of supplier generated documentation..

Warsaw, Indiana, US

Assist in preparation for FDA audit inspection. Site acquired and in process of corporate QMS integration. Review, gap analysis and remediation of Procedures, Work Instructions, Records. Provide guidance on closure of aging legacy CAPA. Writing of Executive Summary Reports to ensure existing records are presented and explained in a clear, concise and.

Wayne, PA, US

Development of Supplier Management Metrics. Working with data from multiple global sites and creating KPIs to identify areas requiring focus.

Eynsham, Oxfordshire, GB

Preparation for recertification ISO13485:2016 AuditGap analysis of QMSRemediation of findingsMitigation of any areas of concern

London, England, GB

♦Conducting and managing supplier assessments to determine the state of Quality Systems and process capabilities at supplier sites in support of ongoing business and new product introductions. Using auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.♦ Ensuring supplier systems are aligned.

Manchester, GB

Development, implementation and training of new Supplier Quality process. Create Supplier Management Procedures.Generate Supplier Management Work Instructions & Templates:Approved Supplier ListSCARSupplier Quality Agreement Supplier Change Management Supplier Audit

Franklin Lakes, New Jersey, US

• Conducting product inspections at various stages of product development phase, involving sample collection, testing, documentation and communication of results;
• Set-up and perform some visual, destructive and non-destructive testing during process development and validation.
• Compile, track and analyse area specific data and report on any identified patterns or trends
• Gather, input and analyse statistical data, assist Quality Engineer in evaluation of a test data.
• Interpretation of the schematics, diagrams and engineering drawings
• Assist Quality Engineer in perform training of production associates on new product quality, test method and operating procedure prior first production runs. Perform attribute assessment on test methods with production.

Eynsham, Oxfordshire, GB

Review and update of electronic Document Management System.Review and update of QMS procedures, work instructions and forms.Review and closure of Change Requests ensuring sufficient evidence for completion of planned actions.Review and closure of Internal Audits including follow up of identified findings to ensure effective closure.

Marlborough, Massachusetts, US

Approval of Change Control requests, ensure sufficient Impact Assessment, monitoring Key Performance Indicators to ensure timely implementation.Genaration of Change Control metrics and presentation of trends to site management team.Chair of site Change Control Review Board. Review, recommend improvements and approval of Standard Operating Procedures, Work.

Eynsham, Oxfordshire, GB

Provide QA Supplier Management consultancy support and guidance for optical medical device products.Lead Auditor performing ISO9001, ISO13485 and Process audits of suppliers in UK, China, and Malaysia.Follow up of audit findings and working with supplier on CAPA plans to ensure effective closure.Develop and implement Purchasing Controls documentation.

Marlborough, Massachusetts, US

Provide QA supplier management support and guidance for pharmaceutical and medical device products manufactured at global sites. Develop BTG Global Quality Standards in activities related to contractors, vendors and/or suppliers. Ensure that departmental objectives are implemented in line with the overall Quality/Corporate goals. Oversee the planning of QA.

Chicago, US

Responsible for qualification, monitoring and improvement of 350+ QMS relevant suppliers to site.Working with a broad variety of supplier sites including medical device, pharmaceutical, sterilisation services, aseptic clean room manufacture and calibration services.Lead auditor performing regular qualification and process audits of global supply.

Amsterdam, Amsterdam, NL

Critical review and approval of medical device and pharmaceutical product batch records prior to QP certification and product release through CofA/CofC.Maintenance of Quality Management System to ensure inspection readiness at all times and development of legacy systems to ensure procedures are compliant to medical device and pharmaceutical.

Amsterdam, Amsterdam, NL

Coordinator for customer complaints - Assessment of severity, evaluation of investigations, monthly review of trends, initiation of CAPA.Expert on powder blending, considering incoming raw material properties and segregation mechanisms within the production environment on batch uniformity and finished product quality.Application of six sigma tools to.

Amsterdam, Amsterdam, NL

Quality control analysis of raw materials, products, packaging and finished goods.Continuous improvement of analytical methods, work instructions and procedures. Identification and investigation of Non Conforming material.

▫ Investigation and quantitative analysis of commercial and developmental pharmaceuticals in biological fluids for pre-clinical trials▫ Developing and validating methods for the extraction of novel drug products in various dosage forms from biological tissues and fluids▫ Assay of compounds and metabolites using limited information, analysis of data and.

Boston, MA, US

Analysis and quality control of high-grade silica▫ On site analysis of plant emissions and processes▫ Participation in meetings to improve laboratory running▫ Investigation and assistance in production problems and providing technical support

Tredegar, Wales, GB

▫ Analysis of stability and production samples using HPLC, GC, FTIR, dissolution, disintegration and various wet chemistry techniques. Following SOPs and working to cGMP

Msc Molecular Modelling, Chemistry

Bsc Pharmacology & Therapeutics, Pharmacology

A-Level, Chemistry, Biology, Mathematics