Management System

Pharmaceutical industry specialist with over ** years experience specializing in validation and standard operating procedure (SOP) development and program management. Subject matter expert on all system development lifestyle (SDLC) documents including user requirements, specifications – both functional and design, qualifications – installation, operational and performance, system builds, test execution, summary reports and traceability matrices. Familiar with all GAMP5 GxP, and ICH guidelines including CFR Part 58, Part 210, Part 211 and CFR 21 Part 11 Expert in developing and compiling compliance metrics for SOPs, deviations, audit findings and corrective and preventative actions (CAPA).

EXPERIENCE

Progenics Pharmaceutical (New York, NY)

Mar- Apr 2017

DocCompliance System Validation Specialist

Served as administrator for the DocCompliance document management system by performing any changes required including adding new users, adding new document types, changing meaning of signatures, changing document storage attributes and any other system changes.

Performed GxP validation testing, including test script creation and execution, on all changes made to the DocCompliance system.

Audited all IT documentation in DocCompliance to ensure that all records are correctly stored and ready for inspection.

Acted as change control coordinator for all IT change controls.

Provided ongoing support and training to Progenics employees on this application.

Updated all IT Standard Operating Procedures (SOPs), due for review or that needed changes.

GalaxE.Solutions (Somerset, NJ)

Feb – Mar 2017

Computer System Validation Lead at Maquet Getinge Group

Reviewed and revised current Procedures and Processes for Software Validation including the level of validation required, the handling of Internal and third party validation and the defining of post go live operations and the change management process.

Performed inventory of all Excel worksheets and all software used in the manufacturing process as part of the quality system.

Created a Master Validation Plan by listing applicable validation protocols and reports to support software or provide a rationale as to why validation is not required.

Reviewed all protocols and reports for proper execution per the applicable regulations/standards including GxP, FDA, and ICH, and defined and remediated gaps.

Validation Consultant at Bristol-Myers Squibb

Jan – Dec 2016

Member of subject matter expert team for the HP Application Lifecycle Management automated testing application.

As validation lead, ensure regulatory risk assessments, requirement specifications, validation plans system implementation plans, release plans system tests, user acceptance tests, and summary reports meet BMS’s standards, GxP standards and ICH standards for the Lab Data Workflow, Karl Fisher (Tiamo) and Clinical Serial Line Management System (CLMS) systems used in the pharmaceutical development group.

Authored validation documentation including risk assessments, requirement specifications, validation plans, test plans, qualification protocols, traceability documents and summary reports

Act as quality reviewer for testing performed as part of a Labware Laboratory Information Management System (LIMS) upgrade release, Symx Electronic Lab Notebook (ELN) and other projects.

Perform periodic review of systems as required.

Validation Analyst at Actavis

Oct 2014- Jul 2015

Performed computer system risk assessments for change controls and projects.

Participated and contributed to the validation of software applications/modules and associated interfaces according to business and internal needs.

Prepared computer system validation documents for change controls, system upgrades, and projects to meet GxP, FDA and ICH guidelines.

Provided compliance and quality guidance to project team during and post implementation regarding computer system validation requirements.

Purdue Pharma, LLP (Totowa, NJ)

Sep 2007 – Sep 2014

Validation Analyst

2011 - 2014

Served as validation lead for IT system projects, SAP system projects and IT change controls.

Acted as a liaison to the IT functional team to ensure all system development lifecycle documentation conformed to company and industry standards.

Worked extensively with the business partnership team for designing test plans and test cases for the user acceptance testing of SAP Projects.

Ensured all system development life cycle documentation meets GxP guidelines and FDA requirements.

Managed the IT department SOP Program and IT SOP deviation process. Provide oversight to the IT SOP program and direction on SOP content, determine ownership and match objectives against current business practices and industry standards. Address and process by authoring and reviewing all deviations against the IT SOPs.

Reported and developed metrics in Trackwise pertaining to IT department for the quality council group, including CAPA, SOPs, and IT SOP Deviations.

Subject matter expert for the electronic document management system used to store all regulated documents.

Continued to perform duties of the validation associate role.

Validation Associate

2007 - 2011

Authored and reviewed SDLC documents including, user requirements, validation plans, validation protocols, test scripts and validation summary reports.

Maintained validation documentation library by assisting with documentation retrieval during external and internal audits and confirmed findings were completed.

Ensured compliance with business requirements, company policies and procedures, and FDA regulations including, 21 CFR part 11 and electronic records and electronic signature. Worked with business owners, IT and Quality Assurance on the full validation and implementation of computer systems.

Acted as subject matter expert for workflow administration of documents approved or archived in the electronic document management system and maintained validation documentation library.

PFIZER (Parsippany, NJ)

2003 - 2007

Systems Validation Specialist

Maintained Pfizer’s U.S. area inventory and order management systems in the highest state of validation, meeting Pfizer’s quality standards, GxP and FDA requirements.

Acted as validation project lead for cross-functional teams for multiple logistics center by ensuring that all GxP requirements met regulatory requirements from creation to implementation, including traceability matrices. Used project management techniques to ensure that the validation deliverables met the proposed timelines by determining the criticality of validation tasks and resources required. Specialist responsible for logistics centers’ compliance with CFR 21 Part 11 and ERES (electronic records and electronic signature).

Analyzed and monitored trends pertaining to validation documents. Supported continuous improvement programs through the use of key performance indicators and metrics.

EDUCATION

MBA, Marketing and Supply Chain Management

Rutgers University (Newark, NJ)

Graduate School of Management

BS, Business Administration

The University of Delaware (Newark, DE)

College of Business and Economics; cum laude

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