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 ComplaintsChange Management

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.

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

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

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.

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.

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 Files.

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, facilitation of SCAR closure. Maintenance of Approved Supplier List within Agile/Oracle.

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. Oversight of activities including supplier Process Validation, Contact Materials, Process Flow Mapping, Process Control Plans, First Article Inspection, Calibration Verification, Phase Gate Review, Part Submission Warrant.

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 compliant manner. Review and advise on remediation of Supplier Management process.

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

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

♦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 with current regulatory requirements, standards and company policies and requirements.♦ Responsible for providing oversight for supplier assessments, escalating issues and leading risk assessments and mitigations as appropriate.♦ Collaborating with key business partners to drive supplier nonconformance investigations and defining effective corrective actions♦ Responsible for the measuring and monitoring of supplier performance against agreed KPIs.♦ Collating and sharing information / data through reports and follow up on identified improvement opportunities. Actively participating and / or drivessite / Global Quality System improvements as required.♦ Quality subject matter expert on cross functional teams during suppler evaluation and selection activities and development of SupplierQuality Agreements.♦ Involved in the development and execution of the annual Supplier Audit plan.♦ Championing Risk Management activities through leadership, facilitation and active support during supplier evaluation and selection activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, businessand product performance.

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

•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 associates. •Specialise in particular are of quality control engineering such as design, incoming materials, process controls, product evaluation, reliability testing, development. •Finalise format of quality documents (Control Plans, Work Instruction, and Test Methods) before final approval. •Non-conforming product review, investigation of deviations or items purchased for product development trials and implementation of appropriate and effective corrective actions to improve product quality and output. •Participate in process mapping, development trials, execution of equipment installation, process and test methods validation. •Liaise with quality engineers to determine quality and reliability standards.•Assist Quality Engineers with process transfers from Project Team to Operations.

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.

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 Instructions and Records.

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 compliant with ISO13485:2012 for management of activities related to contractors, vendors and/or suppliers. Development and implementation of procedures and record templates for Selection and Evaluation of Suppliers; External audit schedule; Quality Agreements; Supplier CAPA; Approved Supplier List.Negotiating and implementing Quality Agreements for suppliers.

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 work load to meet business requirements.Assist in applications for regulatory approval and act as SME during regulatory audits at global sites. Act as a champion for departmental understanding and compliance with the requirements of cGMP including training and support to all departments. Communicate changing trends in regulatory guidance.Responsible for the site Approved Supplier List for contractors, vendor and/or suppliers. Coordinate and support the activities required for evaluation, assessment and approval of contractors, vendors and/or suppliers providing GXP services or products. Responsible for a compliant external audit system through the local External Audit Schedule and the coordination of audits with other sites through the global External Audit Schedule. Lead and participate in audits of contractors, vendors and/or suppliers.Responsible for a compliant system for Quality Agreements for contractors, vendors and/or suppliers, including review and approval of Quality Agreements.Implement KPI for the Supplier Management process. Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review / council meetings, including Quality Measures, QRB and management Review meetings.

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 chain.Assure supplier QMS compliance with ISO 9001:2008 (QMS)/ ISO 13485:2004 (Medical Device QMS)/ CFR 21 QSR (FDA)/ ISO 17025:2005 (Calibration). Approval of Supplier Selection Assessment through robust qualification processes.Improve current supplier quality performance through supplier monitoring and supplier CAPA. Assure and approve CAPA plans are developed, implemented and monitor effectiveness at suppliers. Develop positive relationships and work closely with sourcing teams to manage Supplier Change Notifications/Requests, New Product Introductions and Part Quality/Validation Plans. Interface with engineering, service, manufacturing, quality and sourcing to drive quality improvements that minimize costs of quality, specifically failed on arrival/install (FOA/FOI) issues, field failures and factory defects.

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 standards.Participate in MHRA, FDA and customer audits ensuring any findings/observations are address and resolved in a timely manner through CAPA process.Coordinator for change controls - Approval of change requests, ensure sufficient impact assessment, monitoring key performance indicators to ensure timely implementation.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 measure system performance and gauge effectiveness of improvements.Writing of validation protocol for analytical test methods.Assisting with DQ/IQ/OQ/PQ of new equipment lines.Updating of the regulatory dossiers to ensure current manufacturing procedures match the registered dossiers.

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 measure system performance and gauge effectiveness of improvements.Writing of validation protocol for analytical test methods

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 presentation of results to clients

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

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