SUMMARY:

• IT Project Management
• Effective leadership of cross - functional global teams
• Effectively interfacing with all levels of the organization and all disciplines
• Presentations and public speaking
• Training and coaching
• Technical Training
• Auditing, gap analysis and remediation
• Vendor and software auditing
• Systems, Policies and SOP development and implementation
• Background in research through all phases of clinical trials
• Background in production and engineering
• Twenty years of successful track record in the Pharmaceutical, Biotech and Device Industry. Ten years as a consultant working on projects that resulted in repeat business. Efficiently implemented complex Information Systems with geographically and culturally diverse teams
• Knowledgeable of GxPs (GMP, GCP, GLP, and GDP) Electronic Records and Electronic Signature Rule 21CFR Part 11, PDMA, SOX and computer systems validation SDLC and risk based methodologies. Knowledge of FDA, OSHA, EPA, ICH and European agencies regulations Face to face experience with regulatory agencies personnel.
• Management experience of direct staff as well as in a team environment

TECHNICAL SKILLS:

Proficient in: Word, Excel, PowerPoint, Access, Visio and Microsoft Project, using electronic systems (Documentum, TrackWise 6.0) and Web based applications (Citrix, Sharepoint)

EXPERIENCE:

Confidential

Business Analyst IT

Responsibilities:

• Provided guidance to geographically and culturally diverse IT teams and business units representatives in creating the system specific deliverables for Confidential Global Manufacturing and Research
• Met and worked with users and project teams to define business objectives, workflows, system requirements and architecture, user requirements, and risk assessments.
• Worked with project teams in translating User Requirements into Technical Requirements and Design Specifications
• Developed use case scenarios
• Analyzed and tracked benchmark metrics using industry trends
• Performed design review and internal audit activities across software systems prior to release to sites of new systems, system upgrades and application of software patches
• Responsible for review and approval of resulting Business Flows, User Requirements, Functional Requirements, Design Specifications, test plans, protocols, test scripts, test results, requirement traceability matrix and reports for GMC, DCM, QMS, MES, MRP, ERP, CAPA, FirstDoc EDMS, AERS, Medical Excellence, VAULT (Virtual Access Library of clinical trials and medical information).\, LIMS, CMS, CMMS, SDMS, LMS, CCMS, MMS, SCMS CPIM, Documentum, TrackWise and other complex systems supporting Confidential ’s Research and Manufacturing departments worldwide, using Web applications (Citrix, Sharepoint )
• Reviews and approvals were carried out using paperless electronic systems (Documentum)
• Participated in the management of changes using TrckWise 6.0 for documenting, assessing the impact and approving changes for multiple projects

Confidential

Business Analyst IT

Responsibilities:

• Responsible for analyzing and tracking benchmark metrics and documenting requirements, business flows and qualification activities for TrackWise, Documentum, Adverse Event Reporting and Tracking (SAER), Regulatory Submission Tracking and other IT Systems for Confidential Consumer Health
• Developed project schedule for implementation of these systems using MS project
• Analyzed, tracked and communicated implementation benchmarks
• Developed global policies, guidelines, SOPs, work instructions and templates for computerized systems implementation and qualification taking into account global regulations harmonization, risk-based approach to regulatory compliance, streamlining of the process for increased efficiency and better planning/prioritization of schedules and resources (people and budget).

Confidential

Project Manager

Responsibilities:

• Met with users and IT teams to develop Business Flows, User Requirements, and Functional Requirements for new SAP implementation from blue print to realization for distribution, manufacturing and financial systems
• Developed and maintained detailed project schedule using MS Project. Communicated with stake holders on all relevant issues impacting timeline and resources
• Developed Guidelines and Methodology to carry the project through complete life - cycle
• Conducting across-the organization training on GxP, Good Documentation Practices, methodology and current compliance issues
• Providing methodology, quality practices and validation guidance for non-SAP projects and the overall Confidential organization
• Conducting vendor audits
• Developing retirement plans for to-be-replaced systems.
• Developing Data Migration plans

Confidential

Engineering Consultant

Responsibilities:

• Auditing validation documentation and data for sterile manufacturing facility (Gap analysis)
• Developed new validation strategies and CAPA plan
• Evaluated design, start - up, validation, operation and maintenance of Purified water systems for vaccine manufacturer
• Developing benchmark and new practices for these systems

Confidential

Project Manager

Responsibilities:

• Managed validation of new SAP 4.6c implementation for pharmaceutical manufacturer (SD, FI, CO, WM, PP and QM modules).
• Generated all project documentation using SAP Pharma Solutions as a starting point. Created validation plan, guidelines, and procedures.
• Created documentation, protocols and test scripts templates.
• Reviewed and approved completed specifications, project documentation and test scripts
• Carried out GMP and CFR 21 Part 11 assessment of all BPPs. Conducted CFR 21 Part 11assesments and PDMA assessment of SD module.
• Developed and delivered cGMP and validation training for the project team (including ERES and PDMA).
• Worked with project team to ensure that life-cycle documentation requirements were being met.
• Developed schedule showing all documentation and validation deliverables and integrated these activities with overall project schedule and budget.
• Developed presentation on SAP validation for upper management.
• Developed audit guidelines and SOP.
• Conducted vendor audit and wrote audit report.
• Developed validation protocols and test scripts (IQ protocol, OQ protocols, Data Conversion, Data Migration and security).

Confidential

QA Auditor

Responsibilities:

• Audited validation documentation (all Process validation reports spanning a period of two years) for Vaccine Manufacturer (Gap analysis) and identified corrective action
• Audited Validation Documentation, SOPs and policies for Consumer Products manufacturer (Gap analysis)
• Evaluated the work produced by other consulting firms against current accepted (by regulatory agencies) Industry Practice
• Developed functional requirements and project plan for an Oracle based training tracking system, coordinated activities of other consultants. Developed User Requirements GMP criticality evaluation and test strategies
• Developed guidelines and methodology for a diagnostics facility cleaning validation program
• Completed validation master plans for a biotech research facility (BMS) and a biotech production facility
• Validated two bulk active products
• Provided regulatory guidance to start-up facility.
• Generated required SOPs to comply with regulatory requirements.
• FDA inspected the facility with only one minor observation.

Confidential

Project Manager/ IT Analyst

Responsibilities:

• Communicated with several groups at multiple sites, to define business requirements at each site and for each group. These requirements were integrated into SAP prior to testing.
• Communicated with users and defined business requirements in order to complete integration of FI module.
• Developed policies and procedures (high level and user specific) for CFR21 Part 11 Compliance.
• Conducted Y2K audits for Confidential (now Confidential ) Suppliers.
• Created Validation Master Plans for SAP implementation at several sites.
• Wrote and executed validation test plans for QM, WM, MM modules.
• Executed validation of Autotester (for SAP validation testing) and AWMS (Automatic Warehousing Management System). Integrated AWMS, a legacy system with SAP modules. Conducted investigation and wrote reports on SAP crashes.
• Audited and evaluated LAN and developed SOP revisions and a Validation strategy and plan.
• Conducted audits of data centers for Warner-Lambert Re-wrote policies and SOP’s to comply with Y2K and CFR21 Part 11 (Electronic Records and signatures)

Confidential

GLOBAL TEAM LEADER, VALIDATION MANAGER, SENIOR SCIENTIST

Responsibilities:

• Reporting to the Director of Technical Support, responsible for validation of manufacturing processes and computer systems to ensure FDA compliance
• Responsibilities included establishing documentation, formats, guidelines and SOP s.
• Developed internal guidelines for validation of bulk actives, cleaning validation and validation of computer related systems
• Developed worldwide corporate guidelines for validation for major projects
• Responsibilities included defining validation scope and budget, contractor selection and supervision, as well as directing the efforts of the validation teams and managing the overall validation effort to its successful completion.
• Improved the efficiency of validation projects, reducing time of completion from a year or more to months
• Received award from IT department for validating modules of Peoplesoft in two months
• Reporting to the VP of manufacturing, developed corporate-wide policies on purified water systems
• Leading a global team that implemented the new policies and streamlined the operations of several departments
• The team won a special recognition award.
• Providing cGMP and Validation guidance for outsourcing products in Puerto Rico, Ireland and Austria
• Conducting validation training for other companies and Roche sites in Europe
• Leading a global team that implemented new policies and streamlined the operations of several departments

SENIOR ENGINEER

Confidential

Responsibilities:

• Established and guided the RPI validation group for the HIVID, Klonopin, DI water and Pure Room upgrade in Puerto Rico.
• Had face-to-face interaction with FDA inspectors. All inspections, including Pre-approval inspections concluded with minor observations and facility and product manufacturing approval.
• Lead Engineer for the process design of a major expansion in the vitamin E manufacturing facility. The original scope was a double capacity, and with the contribution of a production team, the capacity was quadrupled without additional capital investment.

Confidential

RESEARCH ENGINEER

Responsibilities:

• Start-up of new automated hydrogenation facility. Developed operators training program
• Served on Validation Committee for new transdermal delivery systems.
• Chairman of Process Operation Review Team for new USP water facility.
• Organized an Employee Participation Team with operators that utilized project experience to continuously improve productivity and quality.
• Start-up of new automated hydrogenation facility. Developed operators training program
• Served on Validation Committee for new transdermal delivery systems
• Chairman of Process Operation Review Team for new USP water facility