Scott Dalton Tel: +44 (0)7972 302 731 23 Twycross Grove, Hodge Hill, Birmingham B36 8LB Email: daltons@uni.coventry.ac.uk http://uk.linkedin.com/pub/scott-dalton/59/921/119

Professional ProfileA diligent and proven senior Quality Management System professional with ~4 years experience in the Medical Device industry. Expertise accrued through a series of promotional and developmental opportunities spanning Quality Assurance, Product Safety and Vendor Assurance groups. This experience, leveraged from a strong BSc Biological Sciences (Hons) degree, has benefited from recent BSI Lead Auditor and NSF Risk-Based-Decision-Making qualifications that have translated in the workplace through pragmatic and methodical application.

Highlights Qualified Lead Auditor ● Risk Management Trained, Solution-Orientated Project Management ● Highly Analytical, Critical Thinker System/Process Trainer ● Valued Team Player Supervisory Experience ● Microsoft Excel Expertise Technical Writing ● SAP, SAP DMS, TrackWise competent

Employment Summary

Pfizer – Infusion Systems: EMEA Regional Headquarters (1) EMEA Senior Quality Compliance . Oct 2013 – Present Day (~4 Years) (2) EMEA Quality Engineer

(3) EMEA Data Analyst – Complaints and Product Safety

1. Coordinate and chair mandatory Quality Management Review and Operational Review conferences to continually assess the state of health of the Quality Management System and collaboratively identify opportunities for improvement amongst senior management. - Monitor and drive compliance across all Quality elements (including Complaints, CAPA, Field Actions, Change Controls, Management Controls, Servicing) against internal (procedural) and external (ISO 13485, Medical Device Directive 93/42/EEC) requirements.- Supervisor to an ‘EMEA Document Control Specialist’, supporting that employee with execution of her remit and surpassing personal goals. - Internally qualified as an SAP-DMS and TrackWise system trainer, the respective approved and validated document control and CAPA Investigation repositories. - Facilitate ad-hoc Nonconformance Review Board (NCRB) meetings to triage new nonconformances relative to risk, assign disposition actions, action owners, and failure codes for trend analysis. Trend nonconformances against predefined Acceptable Quality Limits (AQLs) to assess for identification of systemic risks. - Facilitate mandatory CAPA Review Board (CRB) forums to evaluate Investigational planning and progression status, CAPA proposals and implantation status, Effectiveness of CAPAs to address root cause and reduce nonconformance recurrence likelihood to acceptable residual levels. Trained QA Approver for CAPA Investigation records in TrackWise.- Responsible for EMEA training and iKAT assessment compliance. Stakeholder in the restructure of training module design and the standardisation of tailored training profile global rollout. ------------------------------------------------------------------------------------------------------------------------------------------------------- 2. Post attainment of Lead Auditor status, led a multitude of first and second party audits across EMEA, spanning office-based, manufacturing and servicing environments in >7 different countries. - Designed, developed and implemented a CAPA-driven regional Product Complaint Investigation (PCI) train-the-trainer training programme to review the approved compliant process for invasive and non-invasive PCI activity and record population. - EMEA Single Point of Accountability (SPA) for the Quality processes concerned with a large Third Party Manufactured (Q-Core) product portfolio whereby Pfizer were the acting sole distributor. Regional stakeholder in rectifying quality issues, promoting compliant conduct and designing process improvement strategies (particularly concerning the complaint management process). New Product Launches (NPL) were also a key priority with significant commercial onus. - Maintained steady interaction with Competent Authorities, in particular with HPRA and MHRA (lead competent

authorities), for communicating updates to Field Action activities and for submitting responses/commitments to address competent authority enquiries. – Change Control Committee designee for evaluation/assessment of proposed process/documentation changes. ------------------------------------------------------------------------------------------------------------------------------------------------------- 3. Developed within a small project team a semi-automated excel-based Complaints Monitoring Platform to measure the timely reporting and registration of new complaints originating from 33 EMEA county offices. The model pulled complaint data from inbound site-specific spreadsheets and tracked them against global validated Complaint databases (INET and TrackWise). This platform exposed compliance risks for proactive intervention, and non-conformances for elimination via the CAPA system. Findings were summarised and presented daily to Global HQ. This new process increased regional compliance from 92% to >98%. - Created training slide decks and user manuals for purpose of enforcing, via teleconference, approved complaint handling guidelines across all aforementioned sites. - Maintained a compliance escalation pathway from site personnel to country/regional/global management. - Authored a Standard Operating Procedure (SOP) to formalise the roles and responsibilities of this new Safety department (Reconciliation Department).

Highways Agency – Regional Control Centre April 2013 – April 2014 (1 Year 1 Month: Full-Time then Part-Time) Control Room Operator

- Completed an assessed Control Room Operator and Emergency Call Handling course (>90%). - Used six major software systems to proactively maintain the integrity of the strategic road network, conform to KPI targets and partake in contingency operations protocol.- Implemented tailored incident-management strategies pertaining to traffic collisions, breakdowns, suicide attempts, animals on the network & infrastructure defects; and collaborated with the emergency services, breakdown organisations and managing agent contractors in order to optimize incident response.- Used radio wave transmissions and radio terminology to communicate with Traffic Officers.- Maintained business continuity during Command & Control system shutdown periods.

SVA Limited/Exova Food Analysis and Nutritional Testing Oct 2012 – Feb 2013 (5 months) Laboratory Technician (Chemistry) Microbiologist

Education BSc (Hons) Biological Sciences 2:1 306BMS – Cancer Biology Health and Life Sciences 302BMS - Clinical Physiology Coventry University2012 307BMS – Human Genetics and Society . 321BMS – Advanced Pharmacology and Drug Discovery

Dissertation: ‘An Investigation into the Chemotherapeutic Properties of Artemisinin and Two Synthetic Derivatives within

Hepatocellular Carcinoma Cell-Culture Assays’.Wound Healing assays demonstrated that Artemisinin inhibited HepG2 cell proliferation. The two synthetic derivatives investigated (Artemether and Artesunate) presented comparable In Vitro chemotherapeutic properties. Immunohistochemistry assays were used to quantify protein expression levels, and identified a significant Artemisinin-mediated increase in E-cadherin (a cell-cell adhesion molecule). This indicates that Artemisinins anti-cancer mode of action (MoA) could derive from decreased cellular motility, which would inhibit cancer cell replication and metastasis.

Personal Information

Hobbies: I am an avid swimmer, and have the intention of swimming the English Channel in the summer of 2018. I also have a passion for the outdoors, and regularly compete in national match fishing competitions. My proudest moment was setting a venue match record at Lavender Hall fishery in the summer of 2015, with a 4 hour match weight of 107lb 4oz.

References are available upon request Thank You for Your Time