Archibald Anthony Wilson

Define, plan, coordinate and obtain information requirements to support and launch new products and software releases. Coordinate with multiple resources efficiently and effectively throughout the system development life cycle to ensure that projects deliverable are completed on time, to meet requirements, are implemented accurately and the full impact is understood by the business owner. Interface with internal business users as well as various IT development groups so the needs can be clearly understood, expectations managed and change initiated, Review Current Business Technological and Technical Processes Documentations for Medical Device Implementation. Development of Validation (DQ, IQ,OQ, PPQ ,PQ) Requirement Specifications and Commissioning Documentations. Participate in product design reviews to provide input on functional requirements, product designs, schedules, or potential problems. Review software documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks. Plan test schedules or strategies in accordance with project scope or delivery dates. Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability. Document software defects, using a bug tracking system, and report defects to software developers.

. Oversees day to day delivery and management of validation testing operations, including general direction for assigned work delivery. Manage all directly assigned work activities, generate weekly report presentation to management. Led the development and implementation of structured testing concepts, methodologies and automated testing tools. Establish goals and objectives for appropriate testing cycles. Led, manage and guides test plan development (test schedule, test script, test environment, data, regression requirements, test case development, etc.). Work consists of development and execution and review of System Life Cycle documentation management systems for analytical systems and related software/database packages such as Document Management Systems (DMS) and Quality Management System (QMS). Responsibilities include documentation development, lab system configuration, system testing, system troubleshooting, and Standard Operating Procedure implementation. Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.Prepare, review, revisions and update of IQ/OQ/PQ, validation master plan, test plan and test scripts for validation projects. Revised and updates existing procedural SOPs, plans and protocols for VDS, UFRS, IQ/OQ/PQ test Plan, test scripts, IQ/OQ/PQ Summary Reports and VSR.

• Project Manager and senior consultant for all system validation projects and client audits, • Managed and develop scope, strategy, timelines and deliverables for Skelton validation of Thermal Temperature Controlled Units (TCU), Autoclaves, Warehouse facility, • Revised and update existing of quality program and validation documentations to address revised validation project initiatives (i.e., VMP, Quality Plan, Quality Service Agreement), • Standardized Quality Process development for Validator 2000/ValProbe 1.6, and dynamic testing, • Perform temperature Controlled Units (TCU) testing – CO2 Incubators, autoclaves sterilization, site storage environments, Freezers, Ultralow Freezers, Cryofreezers to verify and validate equipment calibration, computer system software data collection and overall system performance, • Executed remediation activities based on 21CFR Part 11 and cGMP Gap Assessments for laboratory computerized systems used within the Research and Development (R&D) and Clinical facilities, • Write protocols and reports of qualification of analytical instruments as well as procedures resulting from the qualification of these instruments • Installed and qualified updated versions of Validator 2000 and ValProbe 1.60 software to execute re-validation of systems, • Execute Installation Qualification, Operational Qualification, Performance Qualification for Computerized System, Thermal Systems, and Packaging Systems and Labeling Systems, • Developed SOP for operation, calibration and PM of new digital analytical balances and scales located in R&D laboratories. Executed qualification protocols for various models of laboratory analytical balances, • Work with electrical control diagrams for integrating new HMI/PLC based control software for labeling and tracking systems for existing pharmaceutical manufacturing Rimini packaging control system. Worked with programmers, engineers and electrical team in commissioning of HMI/ PLC based SCADA packaging systems,

• Provide expert assessment for acquisition of Thermal systems, • Develop technical requirements for thermal systems acquisition for Pharmaceutical, medical device and thermal monitoring for (Autoclave Validation, Lyophilization, Dehydrogenation, Freezers Stability Chambers, Incubators, Alarm Monitoring, and Warehousing sterilizations) and biopharmaceutical environments, • Assisted with Risk-Based Assessment of Thermal System to ensure fit for business intended use, • Develop validation strategy documentations and business documentations (Templates, SOPs, Plans, and Protocols) to ensure systems and equipment is objectively tested, is of appropriate design, and adequate capacity and will consistently function as intended and operate in accordance with Manufacturers specification and business requirement specifications, • Involve with Documentation, Planning, designing, risk-based analysis for implementation process. Develop documentation for Performance Process Qualification, Installation Qualification (IQ), Performance Qualification (PQ) protocols for validation of thermal processes, thermal monitoring system and Statistical Process Control while leveraging Installation Qualifications (IQ) and Operational Qualifications (OQ) as needed in a new GMP, GxP environment, • Document Thermal Validation Framework (i.e., Validation Activities Validation Strategy, IQ, OQ, PPQ, PQ, Validation Summary Report etc), • Manage re-commissioning and validation activities for Eye Care Rimini Packaging System, • Develop and document Validation Plan, Process Design, Process Qualification and Process Review, • Involve with client to resolve certain issues and problems. Thermal systems include the following equipment, accessories, probes/sensors and software.

Evaluate the feasibility of an aspect of data quality (data reliability) improvement in four specific areas of the electronic medical record (Electronic Medical Records - EMR) Requirements Specification Development and Designation chart: diagnostic coding for a chronic disease [chronic obstructive pulmonary disease (COPD)]; Medication Management, Diabetes CDS Schema; structured specialist referral designation (meta-data) and inter-professional encounter designation.

Perform current process gap re-engineering analysis to assess interrelated and interacting healthcare activities that transforms patient data inputs into outputs to provide seamless tasks for total medication management and Diabetes patient deliverable. Applied quality management standards (i,e. Quality Management standard , ISO 13485, 14971, Process Standard ISO 62304 and Medical Device Product Standard IEC 60601-I during the assessment and re-engineering phases to verify, qualify and validate the outcome. Develop, document and implement processes, and plans procedures to ensure compliance to SEI/CMMI level 3 operations. Ensure effective problem identification, resolution, and tracking of business activities via Gating. Recommend improvements to development and test processes, procedures, and systems to correct identified and potential deficiencies. Participate as a member of the Software Engineering Process Group (SEPG) in process improvement activities. Provide technical and quality support, and guidance to less-experienced internal and subcontractor engineering personnel on quality programs to meet the customers’ requirements. Use current business software such as: MS Word, MS Project, Excel, MS Power Point and Access tools for the development of implemented processes. Develop executable scripts using C+, Java, VB, FPGA, PDL and SQL languages. Develop multi-level graphical analysis process chart for dynamic traceability to link Stakeholder requirements to system requirements and subsystem requirements. Work with SMEs in reviewing and updating “System test procedures, Smoke test procedures, Regression test procedures, System Requirements Specification analysis, Stories definition, Backlog prioritization, Defect management procedures, System and Regression test procedures, to improve software release.

Bachelors Degree Degree in Computer Science PHA in Pharmacology MA Health Administration Clinical Trial Research Certification