Project Manager Software

Summary of Over eleven years in the Pharmaceutical and Information

Qualifications Technologies industries concentrating in computer validation.

Extensive experience analyzing, developing, and implementing

validation programs and strategies while ensuring compliance and

technical expertise on the current regulatory requirements and

industry best practices.

Competent project manager with experience in the development and

the implementation of validation and quality management systems to

ensure compliance with cGMPs, regulatory agencies, and customer

expectations.

21 CFR Part 11 and Annex 11 Subject Matter Expert

GAMP5 and ASTM e2500 Risk Based Validation Subject Matter Expert

Professional 7/2008 to Present ALMAC CLINICAL SERVICES Durham,

Experience NC

Product Manager 05/2012- Present

Managed data integrations for clinical trials which included drug

orders, shipment notifications, site and patient events in

clinical trials.

Supported pharmaceutical and IVRS/ IRT's with setup and

maintenance of data exchanges.

Authored, reviewed and approved data transfer specification

documents.

Developed roadmap, wrote requirements, and worked with software

developers to implement change request.

Supported internal and external users to troubleshoot and fix

issues with software products.

Responded to customer audit questionnaires and inquiries.

Addressed audit findings through training and updating procedures.

Oracle ERP Quality Site Rep 01/2011- 05/2012

Quality Site Representative for implementation of Oracle ERP

E-Business and Oracle Clinical.

Approved all ERES (Electronic Records and Electronic Signature)

system and validation testing.

Responsible for writing, reviewing, and executing testing relating

to QA and QC functionality.

Developed report specifications to ensure regulatory compliance.

Validation Coordinator 10/2009 - 01/2011

Responsible for writing and executing DQ, IQ, OQ, PQ, and Cut-over

Qualification of validation protocols for complex computer system

validation (CSV).

Integrated team member of companies first Agile software

development project.

Developed procedure for utilizing HP Quality Center which included

writing and execution of validation activities, requirements risk

assessment, traceability, and reporting.

Ensured compliance with 21 CFR Part 11, Annex 11, GAMP, ICH, and

SOP's.

Computer Validation of Commercial off the Shelf (COTS) software

including temperature monitoring devices for clinical trial

materials during shipment and GE LabWatch Building Monitoring.

Spearheaded the project to standardized validation templates and

forms

Worked directly with various departmental directors and managers

and advised as validation subject matter expert.

Reviewed and interpreted ASTM 2500 and GAMP5 in order to leverage

IV, OV, and software testing to reduce duplication of testing and

time needed for validation qualification.

Performed Risk Assessment of User Requirements, Risk Scenarios,

and Processes in accordance with GAMP 5 risk based approach to

validation.

Lead teams' transition to a collaborative quality document

management system (LiveLink).

Reviewing and approving System Delivery Life Cycle (SDLC)

deliverables, providing constructive feedback, and ensuring that

the deliverables adhere to associated Standard Operating

Procedures (SOPS).

Served as department liaison with Quality Department to conduct

audits, update procedures, and implement cost savings that

improved processes and reduced deviations.

Technical expert for all change controls involving computerized

systems.

Professional Validation Technician 7/2008 - 10/2009

Experience Responsible for full cycle of project management from inception,

(continued) User Requirements, evaluation of vendor responses, acquisition of

systems, acceptance testing, initial validation, and release into

production

Conducted internal audits of validation documentation for

completeness and adherence to GMP guidelines.

Validation activities included Regulatory Reviews and Periodic

Review reports which insured compliance with FDA, ICH and MHRA

regulations.

Developed, executed, and summarized computer system life cycle

validation documentation including the Validation Plan and Summary

Report, User Requirement Specifications, Requirement Traceability

Matrix, IQ, OQ, and PQ validation protocols and reports for

Temptale Desktop Manager Software and Kaye LabWatch Environmental

Monitoring System.

2/2008 - 7/2008 VALIDATION TECHNOLOGIES, INC. Philadelphia, PA

Validation Engineer

Gained experience in executing IQ and OQ validation protocols.

Performed Installation and Operational Qualifications on HVAC

systems, and Autoclaves

Reviewed executed protocols for completeness and adherence to GMP

guidelines.

Qualified a new autoclave for a manufacturing facility with seven

different load patterns.

Responsibilities included writing and executing the Installation,

Operational and Performance qualification protocols, performing

Process Development runs, developing load patterns, procuring and

coordinating BI testing, and writing the final qualification

reports

Wrote, developed, and executed IQ and OQ protocols for HVAC

Systems.

Responsible for developing, writing, executing, temperature

mapping, and summarizing an IQ and OQ for a laboratory

refrigerator.

Performed temperature / humidity mapping for environmentally

controlled rooms and warehouses.

06/2007 - 11/2007 SHERATON MAUI RESORT Maui, HI

Director of Fun (sub-contractor)

Led the execution of guest leisure entertainment

Manage, hire, interview, train recreation attendants

Accountable for the creation, publicity, marketing, tracking and

follow up of guest programming

Liaison between resort and BAM management and employees

1/2003- 05/2007 CX CORPORATION Greensboro, NC

General Manager 11/2003- 05/2007

Responsible for day to day operations of Commercial Software

Development Company specializing in court case management

Oversee staff of Developers, Sales, Marketing, Testing and Support

Staff

Application development, customization, configuration, project

planning, budgeting and costing

Project Manager of multiple projects including company's first

international venture

Guide internationally based developers to meet project deadlines

and to satisfy user requirements

Negotiated and drafted contracts for US and International

customers, including Fortune 100 companies

Develop test plans, procedures, validation, and SOPs of custom

proprietary software

Responsible for user documentation and interaction from initial

contact, to pre-sales demonstrations, to design, to customer

acceptance testing and implementation

Interact with clients to document functional and non-functional

business requirements

Translate user functional requirements into software change

request for developers

Develop training material and train end users such as Superior

Court Judges, Legal Professors, Attorneys, NC Institute of

Government

Built new client relationships and managed client expectations in

order to gain new and repeat clients

Professional IT Manager CX CORPORATION

Experience 1/2003- 11/2003

(continued) Installation of multiple high-tech courtrooms including custom

wiring for servers, touch screens, plasma, LCD projectors,

document cameras, scanners, video conferencing, printers

Responsible for 24x7 network operations, backup, maintenance and

support

Telephone, email, IM and onsite support of specialized NC Superior

Court, Law Schools, and end users.

Pricing, quotes, and order fulfillment of all hardware and

equipment

Design wiring diagrams and plans based on architecture blueprints

Worked with Administrative Office of Courts and gained approval

for software acceptance.

Installation and support of 3rd party healthcare and dental

practice management systems

Implementation of telemedicine videoconferencing for healthcare

clinic

Education Bachelor of Science in Business Management

University of North Carolina Wilmington

References available upon request

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