Scott Hayward Email & Phone Number

Didcot, Gb

Oxford, England, United Kingdom

Oversees and drives quality efforts from our suppliers to the distribution of our products, reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation. Developed, establishing, and maintaining quality assurance programs, policies, processes, procedures, Training and controls to ensure that product performance and quality meet established standards and agency regulations. Have broad decision-making responsibilities and be accountable for the accuracy and timeliness of those decisions, as well as for deploying organizational resources to resolve issues. Drive Continuous Improvement efforts for QA Department and collaborate with all areas of the business to on matters of GMP and Quality, striving to achieve a mature proactive quality culture. Liaise with other departments to drive awareness of Quality KPI and ensure successful completion of tasks, on time and in full. Ensure activities are aligned with industry best practice, company policies and procedures and are cGMP compliant. Liaise with Clients on matters of Quality and provide support during client audits and regulatory inspections. Assures Site Validation Master Plan is followed.

Abingdon, England, United Kingdom

RESPONSIBILITIES – Drive Continuous Improvement efforts for QA Department and collaborate with all areas of the business to on matters of GMP and Quality, striving to achieve a mature proactive quality culture. Liaise with other departments to drive awareness of Quality KPI and ensure successful completion of tasks, on time and in full. Ensure activities are aligned with industry best practice, company policies and procedures and are cGMP compliant. Liaise with Clients on matters of Quality and providing support during client audits and regulatory inspections. Assures Site Validation Master Plan is followed.OTHER ACTIVITITES - Batch disposition for Finished Products • Product Quality Reviews (PQRs) • Customer and supplier complaints and recalls • Review and approval of QC method validation, calibration, and qualifications • Review and approval of protocols and reports for stability and forced degradation studies • Approval of periodic water and environmental monitoring reports • Approval of non-compliance investigations e.g., deviations, OOSs, CAPAs and Change Controls • Production batch record reviews (executed and master records) • Prepare CoC statements, BSE/TSE, and other certifications • Raw material code assignment and risk assessments • Review and approval of production equipment (minor and major changes, qualifications, and calibration) • Review and approval of specifications for RMs, NTs, PAs, and PKs • Preparation of QA reports, reviewer of documentation • Review and approval of manufacturing and cleaning documentation e.g., BPGs, BSGs, RCGs, PTL/CLs, decontamination certificates.

Chipping Norton, Oxfordshire

To be accountable for all quality and compliance aspects related to the manufacture and release of product for Cotswold site, so that supply levels are maintained, issues are communicated and resolved efficiently.Responsible for the quality compliance of all aspects for product quality from site and for driving improvement initiatives etc.Responsible for the release of product from the site that meets specification to EU GMP and ISO 13485 and FDA regulations. (incoming drugs /cold chain),To be responsible for the Quality Scorecard so that all areas of the business support the measuresBe the primary decision maker for Quality on all aspects of Quality compliance with regards to the OM and customer’s product lines.Accountable for quality compliance relating to customer’s product – including exceptions, change control, audits, co-ordination of other quality activities (e.g. validation, risk management and regulatory affairs) and liaising with batch releaseAccountable for the Quality KPIs reported within the monthly scorecard issued by the customerManage the customer interface with Owen Mumford Quality, with direct access to the Key Account Customer’s TPM Quality Manager.Overall responsibility for all document reviews and approval for area of responsibility related to key account customer’s productManage all quality activities for batch release, testing and validation documentation progress plus Operations team for batch manufacturing progress, exceptions, investigations as requiredLead and host all external audits from the customer, MHRA, FDA and Notified Bodies applicable to the Cotswold siteMaintain EU GMP, ISO13485 / GMP / FDA / Medical device standards within Quality and through the Cotswold site manufacturing, Wearhouse, tooling, raw material, Drug room, Moulding etc.. Responsible for metrics, dashboards and KPIs with customer to monitor performance routinely

Chipping Norton, Oxfordshire

Responsible for preparing all areas of the Cotswold site for FDA, SGS, MHRA and Key audits Drive continuous improvement initiatives and other customer-related projects.Host and support audits, e.g. Notified body, FDA and key account customer audits (AbbVie). Responsible for managing quality related activities with designated customer’s inline with the Quality Technical Agreements.Provide quality support and input to Design and PFMEAs. Support and host customer visits and deliver key information as requested by the customer.Liaise with the customer to determine metrics and monitor data gathering. Prepare and present at customer Business Reviews the mutually agreed performance indicators (KPIs) remediate performance falling below the agreed targets.Work with other areas within Quality and across the business (e.g. Moulding, Assembly, Incoming raw material, Warehouse and Operation’s, Design) to drive, support and create improvements.Day to day managing of the Key Account Quality Team.Manage quality related activities with the key customer with them on manufacturing /testing of commercial delivery systems lots and related exceptions.Responsible for the key account Quality budget.Negotiating with the customer/Notified bodies on any corrective actions required and managing through to closure all aspects of audit evidence books.Lead the planning and implementation of key projects within the scope of Key Account. Responsible in recruitment development and training of new members of staff, managing a team of 3 quality members, to enable achievement of site and divisional goals.Strategically leading cross-functional teams for all major quality investigations for the site in an effective and timely manner.

Chipping Norton, England, United Kingdom

Deputy for Site Quality Manager; responsible for final batch release, QC incoming, release testing labs, exception complianceand, customer controllers and Manufacturing QA team. Day to day managing of the customer controller’s and manufacturing QA teams. Manage quality related activities with key customers /QP’s, communicating with them on manufacturing /testing of commercial drug/delivery lots and related exceptions.

Maidenhead, England, United Kingdom

Provide QA Support for Pharmaceutical products within the Medical Division of Abbott International. (AI medical) Deputise for the QA Manager for AI when required for all aspects of their position when necessary e.g. product action/recall, conduct quality complaint and adverse event training, lot hold, Manage and operate the UK AI & Abbott Nutrition International CAPA process within head office.Manage the complaints process, responsible for managing Quality complaints specialists. Responsible for creating/ presenting quality metrics for the AI Management Review Meetings. Conduct Internal audits for AI and ANI and the Abbott Compliance audits as required.Provide QA (CAPA) training as required within AI. Conduct Complaint training at each month induction program and at the annual Accounts/Sales seminars Manage the divisional, internal and regulatory (MHRA) inspections. To act as QA Manager and assist the QA Director in the event of product recall within AI.Review and interpret divisional QA policies ensuring that local procedures are implemented and are compliant to divisional / regulatory requirements.To conduct supplier audits, create / review technical agreements and quality plans between Abbott International and Abbott Nutrition and their suppliers.Other responsibilities covered during maternity leave whilst maintaining my role as Senior Quality Assurance officer, Committee Secretary to the (UK ACC) Abbott Affiliate Compliance Director. July 2008 to Nov 2011

Didcot, England, United Kingdom

Deputise for Lombard’s Quality Assurance Director when required for all aspects of their position.Acting QA Manager, responsible for product action/recall, QA training, creation of QA documents, approving release of sterilised products to market, internal and external audits, Calibration, CAPAs and Customer complaints. Responsible for the QA/QC team, day to day managing of the coordinators and specialists for the following processes; Incoming rawmaterial, product final release, complaints, CAPAs, calibration, audits, documentation control and HSE. To organise and managed the QA team during ISO 13485 audits (conducted by TUV). Rollout procedure and policy training to QC and manufacturing personnel. Support Clinical reps with QA guidance e.g. GMP, ISO 13485 etc..Completing supplier audits, facilitate administration of internal audits.Managed the documentation control process. Follow up on audits to ensure closeout of non-conformances.

London, England, United Kingdom

Maternity Cover Conduct monthly assessments of all stores in London, present summary reports to Quality Director Coordinate the QC inspectors on carrying out the inspections to ensure the level of quality of goods in stock and of goods inwards.Conduct in-depth investigations and report back to design teams in Head office London. Plan day to day work load of the QC inspectors to ensure product demand is met.Plan QC priorities in accordance the business objectives, within the time frames that have been defined in the Key Performance Indicators.Report on day to day basis any deficiencies to Head office control teams and divisional teams.Responsible for creating and developing SOPs for both for Habitat QC activities.Monitor on weekly basis, items on the QC hold warehouse inventory, manage the stock which is listed and ensure backlog and scrap is kept to a minimum.Manage and control product recalls within the warehouse and ensure returns are co-ordinated. Maintain effective communication with QA Director and Operations.Inspection of product care and handling within the warehouse with the sub-contract logistics provider. Communicating any deficiencies found with the sub-contractors with the Quality Director

Abingdon, England, United Kingdom

Medisence (Abbott Diabetes Care) Support an ongoing supplier audit schedule by conducting audits and monitoring the adequacy of approved suppliers’ quality systems. Suppliers include significant service providers. . Update and maintain ADC Ltd Supplier QA procedures to ensure compliance with Quality System, Regulatory and Abbott Corporate requirements.Complete External Suppliuer Audits for (cGMP) ISO 9001-2000/ISO 13485 Provide recommendations to the business for supplier selection and performance monitoring activities (including service providers and consultants). Develop effective business relationships with suppliers to ensure their quality systems meet medical device requirements (as applicable) and ADC’s quality requirements. Provide investigation support for material troubleshooting for production related supplier issues. Provided critical input resulting in successful internal audits for cGMP in device manufacturing areas. Monitored and ensured compliance with the quality system, GMP and regulatory requirements for the diabetes monitoring systems manufactured within production. Carried out internal and external audits to ensure both production and suppliers met both company and regulatory requirements as applicable.Generate key documentation for both manufacturing and supplier environments, including SOPs and reports.

Abingdon, England, United Kingdom

Manufacturing Quality Assurance Specialist, Medisence (Diabetes Care) Monitor and ensure compliance with the ADC quality system, current good manufacturing practice (cGMP) ISO 9001-2000/ISO 13485 and regulatory requirements. Provide quality/compliance decisions on product during processing and manufacturing. Participated in projects both as lead, and assist, enhance and further assure the quality system and products e.g. created tracking MQA observation system ensuring compliant to 21 CFR Part 11. Maintain the effectiveness of the quality system at the site in accordance with divisional requirements and applicable regulations.Operate as an integral part of the supply/manufacturing and QARA teams.Responsible for documenting and processing any Manufacturing nonconformities

Deploma In Engineering, Electrical And Electronics Engineering, Betec

Gcse'S

City & Guilds Of London Institute, Electrical Instalation Compentances, Levels 1 & 2