Project Manager System

AUDREY GREENE

*******@***.***

*** **** *****

Middlesex, NJ 08846

Home Phone 732-***-****

Cell Phone 914-***-****

SUMMARY ~Achievements in System Development Life Cycle (SDLC) IT Infrastructure and applications, quality systems engineering, commissioning and computer process validation. Expertise in failure mode analysis, risk determination and assessments for validation, validation master plan implementation as well as 21CFR Part 11, 211, 210, 203, 59, 820 and GAMP 4/5 validations.

~Skilled in leading high performance teams to meet tight deadlines, streamlining processes and procedures to deliver innovative solutions, cutting costs and improving efficiencies, managing multiple projects, designing and deploying integrated networks and automated validation systems and ensuring timely product launches through FDA audit compliance.

~Over six (10) years of Hands on of development, review, configuration of user requirements, and trouble shooting of TrackWise. This includes development, test and production environments.

PROFESSIONAL EXPERIENCE

07/09-11/09 PARAGON COMPUTER PROFESSIONALS, INC.

CLIENT- BRISTOL MYERS-SQUIBB (BMS) PRINCETON, NJ SENIOR VALIDATION SPECIALIST

• Review and approve validated test scripts through automated HPQC System and paper of SAP Support Packs and webMethods projects.

• Maintain close communication with stakeholder and team members to keep apprised of computerized system needs, impacts on computer validation status, and other relevant concerns.

• Develop, review and approve computerized system documentation such as:

• Validation Plan,

• CSV Risk Assessment

• Test Plans

• Test Summary Reports

• Trace Matrix

• Validation Summary Report

• Provide guidance on quality issues that affect the integrity of the data and or system

• Maintain a working knowledge and awareness of regulatory requirements

• Managed day-to-day client interaction on webMethods projects

03/08-4/09 BARR PHARMACEUTICALS, INC. WOODCLIFF LAKES, NJ

IT INFRASTRUCTURE COMPLIANCE LEAD

• Managed and reviewed requested proposed Infrastructure Change Controls to be submitted to the Change Authorization Board (CAB) for presentation and risk assessment to meet GAMP4/5.

• Manage and review Infrastructure Change Controls through GxPharma, TrackWise and SAP.

• Developed. Reviewed and approved SOP’s, Policy Guidelines, and Work Instructions for IT Infrastructure and related departments.

• Review and process IT Infrastructure IOQ’s and documentation for hardware, datacenter equipment and server software.

• Managed the strategic aspects of large engagements and mitigates any risk on internal IT Infrastructure projects

• Responsible for developing /quality review of validation documents

• Periodic audits of IT Infrastructure System Maintenance Forms

• Participated in Disaster Recovery Guidelines.

3/03-4/07 KOS PHARMACEUTICALS, INC. CRANBURY, NJ

Manager, FDA Compliance and Computer System Validation, Project Manager

• Hands on manage a staff of 4 FDA Compliance and Computer System Validation engineers. Responsible for hiring, raise reviews, etc…

• Liaison between regulatory agents and IT. Represent IT and interface with external compliance auditors such as FDA and EMEA regarding hardware and software Computer Systems Validation (CSV).

• Established a corporate computer validation department to address FDA regulatory and compliance requirements. Chair the Computer System Validation Steering Committee (CSVSC).

• Act as technical expert in FDA computer and equipment audits. Prepare audit reports based on audit results. Assign risk ratings to audits.

• Organized and developed a computer vendor management and auditing program for all of the cGXP facilities.

• Conduct domestic/international vendor audits of software and equipment suppliers.

• Managed scope and mitigates risk across projects (JD Edwards, TrackWise, Documentum,

• Manage the cGXP software validation program for compliance to regulatory requirements. Manage the activities of Software Validation Consultants.

• Participate in preparation of commissioning documents for SCADA (Supervisory Control and Data Acquisition) systems, DCS (Data Control System), PLC (Program Logic Controllers) and BMS (Building Management Systems.

• Participated in Design Review for standalone and embedded systems.

• Reviewed and approved Installation, Operation and Performance Qualification Protocols to support validation of equipment.

• Prepared the annual budget for computer validation activities. Oversee an annual computer validation budget of $4.5 million.

• Participated as Kos Project Manager on all decision-making processes that govern the validation efforts for all computer/equipment automated systems. Hands on participation in implementing systems. Systems included but not limited to: JD Edwards, Documentum, SAP, TrackWise, EDMS/First DOC, CTMS Clintrial Management System, TotalChrome, laboratory equipment, laboratory equipment, Agilent CDAS (Chromatography Data Acquisition System), Building Management System (BMS), Clintrace 4.2, AHU (Air Handling Units), Steam Boilers, air compressors, Mitsui Tablet Press. These documents covered testing, specification and acceptance.

• QA representative (Project Manager) for remediation of legacy automated equipment.

• Reviewed and approved user/functional requirement specifications for computer and automated quality systems.

• An internal consultant on the selection of new software solutions for part 11 and predicate rule compliance.

• Coached and instruct personnel in Computer System Validation (CSV) and protocol preparation of equipment and process equipment.

Selected Accomplishments:

• Created internal system validation team, reducing annual SDLC project costs by $4 million. Company lacked internal computer and automated equipment teams, requiring outsourcing of validation projects. Costs per project ran to $600K for each SDLC audit. Developed SOP and implemented best practices. Recruited and led in-house team for new computer system validation, reducing individual project overhead to $100K.

• Implemented computer and automated systems validation process, allowing FDA approval and new product launch. Company was reluctant to establish computer systems validation. Researched and created policy to model SDLC. Set up steering committee to communicate policy. Created new department within QA. Completed live, ongoing two-year FDA-approval audit for new product, receiving startup go-ahead.

2/98-01/03 CARIMAR INC., LAKE HOPATCONG, NJ

CLIENT: SCHERING-PLOUGH, KENILWORTH, NJ

Senior Compliance Specialist

• Assisted Compliance Project Manager in planning and setting priorities.

• Provided support to Research Information Services (RIS) project teams through answering questions and compliance guidance.

• Evaluated company compliance of 21CFR part 11.

• Developed SOP and validation template systems.

• Wrote all or portions of validation master plans, IQ/OQ/PQ protocols and test scripts.

• Member of the RIS SOP Committee. Overhauled all RIS SOP’s and existing templates. Reviewed, developed, maintained and enhanced RIS SOP’s and templates.

• Dimensions Source Code Control, Dataval, LMS, Server IQ/OQ and various other projects.

• Reviewed functional requirements, designed specifications and other related documents based on the SDLC approach.

• Evaluated automated testing tools.

CLIENT: WARNER-LAMBERT/PFIZER, PARSIPPANY, NJ

Technical Consultant

• Validated GUI on client and workstations for ConsumerLINK. Reviewed functional requirements and design for ConsumerLINK. Reviewed architecture of ConsumerLINK System (LAN/Servers/Client) for all sites.

• Change Control Committee representative for corporate IS QA/validation.

• Audited, inspected and assessed activities to verify compliance of Training Records Information Management System (TRIMS), Documentum and Manufacturing Execution System (MES) with validation plan, company policies, cGMP’s and validation procedures.

• Prepared and executed installation, operation, performance qualifications and 21 CFR part 11 protocols for computer hardware and software applications of TRIM/ConsumerLINK/Test Director.

• Prepared weekly validation status reports for Project Manager.

• Attended project meetings to maintain planning activities.

• Traveled to other sites to execute hardware and application protocols.

• Validated the following applications: TRIM/ConsumerLINK/Test Director.

• Designed, developed and wrote Standard Operating Procedures (SOP’s) for Systems: Backup & Restore/System Standards/Security.

• Developed and implemented a worldwide training program addressing computer validation requirements within the FDA arena.

Selected Accomplishment:

• Established software testing process, ensuring Pfizer systems continuity, saving $1M. Corporate Information Systems would not allow integration of new and current software due to program schema issues. Led team in implementing software testing to validate system capability and anticipate date variability. Identified required patches to existing software, ensuring seamless operations.

2/73-10/96 HOFFMANN LAROCHE, NUTLEY, NJ

Group Leader, (1986-1996)

• Hired/managed multi-disciplined diverse staff for positions ranging from Senior Laboratory Technicians to Senior Scientists.

• Evaluated and troubleshot manufacturing, quality and compliance concerns CDER and FDA regulated products.

• Participated in technical sessions for evaluation of new technologies and raw materials.

• Developed qualification protocols for complex, highly automated laboratory equipment.

• Developed and reviewed new SOP’s and direction for testing new products.

Selected Accomplishment:

• Developed automated lab process, reducing product backlog 87%. Lab faced high backlog of drugs in laboratory test process. Sourced and selected automated system to increase lab productivity. Replaced wet-method titrations done by color indicators with auto-titrators, running 24 hours a day. Implemented continuous testing schedule. Eliminated laboratory backlog and significantly improved efficiencies.

Area Supervisor, (1978-1985); Associate Supervisor, (1975-1978); Chemist, (1973-1978)

EDUCATION MS, Chemistry, Brooklyn Polytechnic Institute

BS, Chemistry, City College of New York, CUNY

REFERENCES Furnished Upon Request.

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