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Date Added: 15/03/2004 18:38:15

validation specialist
Summary

Over 6 years of IT experience with 3 years of specialization in FDA Validation in the Pharmaceutical Industry. Experienced in System Analysis, Design, Development and Quality Assurance Testing of Web based, Client/Server and ERP applications. Well versed in the Document Change Control Techniques and Methodologies. Strong experience in Computer Systems Validations (CSV) by ensuring compliance to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries. Good Analytical, Technical, Organizational skills coupled with excellent written and verbal communication skills.

Skills

Languages: C/C++, Java, Java Script, Xml, Html, Dynamic C, Pascal, SQL, Fortran, Cobol, IBM 370 Assembler
Hardware, Operating Systems & Packages: Sun, HP-UX, VAX/VMS, Windows NT/2000, Unix, Lotus Notes, Track wise, Business Objects, MS Excel, MS Word, MS PowerPoint, MS Project, Visio2000, SAS v8.2 and PGP Software
Web Technologies: BroadVision API, Java, Documentum 4i, EDMS Documentum, Test Director 7.0i, JSP, Servlets, Applets, HTML, ASP, CGI, PERL, Macromedia Flash/Dream weaver ver4, Adobe Photoshop-pro
Databases: Oracle 8i/9i, Sybase 4.9.2, MS-Access 7.0
GUI: Developer 2000, Visual BASIC 6.0, and Crystal Reports 6.0/7.0
Methodologies: OOA/OOD, UML, Rational Rose

Education

M.S. Computer Science, May 1997
Fairleigh Dickinson University, New Jersey
B.S. Accounting, December 1991
Kean University, New Jersey
B.S. Biology, April 1988
Bangalore University, India

Experience

(08/02-Present) Senior Validation Analyst

Department: Medical Systems Research Group - Secure Data Application (SDA) for LIMS/MCAS

Worked on all phases of life cycle of a project for Secure Data Application (SDA). The purpose of the Secure Data Application (SDA) project is to provide a secure and regulatory compliant environment for Amgen employees to exchange data with external Partner(s) and Contract Research Organizations (CRO). To ensure data file security and integrity, all data files will be encrypted using PGP prior to placing on Secure Server. The software incorporates a simple mechanism to allow both Amgen employees and external partners to upload files to the appropriate folders on the Secure Server via FTP mechanism. This SDA system brings Amgen external data transmission system into compliance with US FDA Title 21 Code of Federal Regulations (21 CFR Part 11) for Electronic Records and Electronic Signatures. A dedicated module, Data Transmitter (as a component of Secure Data Application) is built to interface with the Material Control Automation System (MCAS). MCAS will notify Laboratory Information Management System (LIMS) of raw material receipts and LIMS in turn will send sampling plans, sample data, and status changes upon completion of testing to MCAS.

Responsibilities:

· Involved in Complete systems development life cycle and documentation.
· Responsible for ensuring that all documentation and procedures comply with the FDA 21 CFR Part 11 and cGxP guidelines.
· Extensive interaction with IT, Users, Business Owners, and ISQA departments to develop and maintain validation procedures and Gap Analysis documents.
· Responsible for creation of Project Checklists/Task Plans, Requirements Specification for Purchase Systems, Package Configuration Specification, Validation Plan, Validation Summary Report and Security Account Management Procedures using PQM process and Polaris.
· Responsible for creating IQ/OQ/PQ Protocols and Test Reports for the whole process using PQM process and Polaris.
· Involved in creating IQ and OQ test scripts for calculations using SAS.
· Responsible for creating test scripts, executing test cases, reviewing and verifying test results, identifying and reporting issues and providing summary test reports.
· Involved in creating and updating of Standard Operating Procedures (SOP).
· Performed User Training.
· Involved in creating transaction tables on LIMS and MCAS databases and writing pl/Sql procedures and triggers for the transfer of required data between LIMS and MCAS.
· Involved in preparing Change Request forms and discussing with the Change Control Committee for defining the Changes.
· Involved in creating of folders and User Account Credentials on Win2000 Server.
· Document all phases of system life cycle as required by FDA regulations under 21CFR Part 11 (Electronic Records and Electronic Signatures) and successfully complete QA checkpoints and also involved in FDA auditing.

Environment: Windows NT/2000, HP-UX, SAS, Citrix, PVCS, Oracle 8i, GCP/ GLP, Reflections for Web FTP, SQL*LIMS, Documentum, Microsoft Office, Visio2000, Pretty Good Privacy (PGP) encryption/decryption Software, PL/SQL

(02/02-08/02) Validation Specialist

Department: Clinical Research Group - Clinical Trial System (CTS)

Participated in a project for building Clinical Trial System (CTS), which aids in gathering of data in an electronic format to simulate the Protocol worksheets. CTS consists of several components of which Data Collector is a primary one, which implements the remote data entry. It is developed using the vendor supplied Penergy Toolkit software and is a laptop-based component of the CTS for security reasons. The system is programmed with data validation routines that facilitate appropriate data entry. Personnel employed or authorized by Abgenix enter patient data and electronically transmit the data to the server database repositories. This data transmission allows rapid review of clinical data by Abgenix staff. Since current clinical data is available to Abgenix staff instantaneously, concerns can be addressed on a timely basis in order to meet business needs.

Responsibilities:

· Preparation of protocol & FRS Metadata report from clinical trials.
· Writing SQL queries to generate reports for the Metadata verification purpose.
· Prepare test plan documents for the unit testing, conduct unit testing following stringent quality assurance (IQ/OQ/PQ) guidelines and verify the data dumps to evaluate if the data is correctly transmitted to the backend Oracle database.
· Worked with users to ensure that the test scripts are accurate and proper.
· Document all phases of system life cycle as required by FDA regulation under 21 CFR Part 11 (Electronic Records and Electronic Signatures) and to successfully complete QA checkpoints.

Environment: Oracle 8i, GCP, Test Director 7.0i, Source Safe, PL/SQL, PLC, Windows NT, HP-UX., CRFTrack, CRFScan, ISIFile

(10/00-01/02) Computer Validation/QA Analyst

Department: Clinical Trials and Audit Analysis Department – Clinical Trial Information System

Worked on a project to build Clinical Trial Information System, which is developed to maintain a data repository of records pertaining to the clinical trials performed by Bayer Pharmaceuticals. Worked as a Validation Analyst on two modules, Equipment Tests Tracking (ET) and Investigative New Drug System (INDS). The functionality of the modules varied from recording tests conducted on medical equipment to ascertain their viability to storing the financial data. The modules also included a feature to report the progress and status of the medical studies. Periodic reports were generated by the application for various levels of management for decision and control purposes.

Responsibilities:

· Assured that all validation documentation such as IQs, PQs, Process Validation, and Software Validation documents are in compliance with cGxP regulations
· Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21 part 11 including Validation Plan and Protocol, Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification and Validation Summary Report.
· Involved in the development of Validation/Test Protocols (IQ/OQ/PQ) including all applicable Standard Operating Procedures (i.e., Change Control, Backup and Restore, Business Continuity Plan, and Training).
· Validated processes and equipment (Hardware, Accessories such as Printers and Scanners) utilized in active pharmaceutical ingredients (API) manufacturing cGMP environment.
· Performed Installation and Operational Qualification (IQ/OQ) for facilities, equipment and systems and was involved in the Change Control and Change Management Testing for FI, SD & HR modules and regression tested the Test Protocol.
· Involved in defining Functions and Requirement Specifications and preparing the Gap Analysis Report identifying prioritized regulatory risks and exposures.
· Created reports summarizing the SDLC approach, methodology, and validation readiness.
· Involved in complete manual testing of the application.
· Tracked the validation progress through Validation Assessment Reports.
· Clearly identified closed and open systems according to 21CFR Part 11.
· Checked whether the execution of the e-sigs are audit trailed.
· Tested for signature manifestations in compliance with 21 CFR Part 11.
· Base lined the Test Plan, Test Criteria & Project Schedule by walkthroughs and review meetings.
· Conducted Regression Testing on various builds of the application and reported the defects (created by QA Testers) to the Developers using TestDirector software.

Environment: Windows NT, Sun Solaris, HP-Unix, Oracle 9i, PL/SQL, Test Director, cGMP Environment, In-house Bug Tracking System

(09/99-10/00) Programmer Analyst

Worked on the site re-design project for Merck-Medco. The site was re-designed to confirm to U.S. Govt’s regulations while enabling the firm to conduct e-commerce with mail and retail clients using BroadVision software. The responsibilities included designing and developing several components, which are referenced by the Java Scripts for creating pages related to eHealth modules on the site. The eHealth modules display health related information such as Adam’s health articles, Pharmaceutical research papers, health advice and miscellaneous information related to diseases and their related drugs. The components are used by Java Script pages to access the database tables, retrieve information from legacy systems and create the html pages on the site. For the same project, involved very actively in creating SOW documents, receiving the functional requirements from Business, preparing detailed design documents and creating test cases.

Environment: C++, BroadVision API, Windows NT, HP-Unix, Oracle 9i, PL/SQL

(07/97-09/99) Systems Analyst

Worked on a Project for a Customer Care System for a Hospital chain in New Jersey.

Participated in the design and development of a Customer Care system for a hospital chain in New Jersey. The system was designed to assist the hospital administrators and customer care specialists in the areas of patient registration, status updates and also aid the billing system by providing the information related to all the services provided to patients during their stay in the hospital. Responsibilities included receiving functional requirements from the hospital administrators, preparing the functional specifications, creating the detailed design documents, developing and testing various components of the system.

Environment: C++, Sun, Oracle 8i, PL/SQL

Participated in a Project for a National Home Improvement Chain.

Worked on a project for Inventory Control System. The System was designed to manage the inventories of all the Home Improvement products that are sold by their stores. The system was used extensively by the individual Store Managers and Controllers at Warehouses through their Intranet site. Participated in various phases of the life cycle of the project from its inception to the delivery. It included preparing the Functional requirements, writing detailed Design documents, Coding and Testing. The coding effort consisted of writing APIs as part of back-end Class Libraries to access the Legacy systems for the information related to inventories. The Class Libraries were used by the Presentation layer to display the information to the end-users. Also participated in the presentation effort by writing Java Scripts and html. The testing effort primarily consisted of verifying the functional requirements by functional and regression testing of the System.

Environment: C++, Sun, Client-side Java Scripts, Html, Oracle 8i, PL/SQL, Rational Rose for Analysis, BugTrack software

Worked on a Project for a leading Commercial Bank’s Credit Card Division.

Worked on the design and development of Customer Care System for their Credit Card division. The System was designed to process customer information and generate daily and weekly reports for upper-level management. Responsibilities included receiving functional requirements, writing design documents, developing and testing. The development effort consisted of writing code for accessing the data repositories and preparing daily reports for the upper-level management. Quality Assurance effort consisted of participating in the functional, regression and stress testing of the Customer support system.

Also worked on a project for the same bank’s Accounts Division. Involved in the design and development of RAFSS (Rapid Access Financial Support System) for the Corporate Accounts Group. The system was designed to accept the information relating to Revenues, Accounts payable/receivable, Expenses, etc. and prepare Financial Reports. The reports are intended to give information to various mid to high-level executives in the Company. The end-users access these reports through their Intranet site based on their privileges/entitlements.

Environment: C++, HP-UX, Client-side Java Scripts, Html, Oracle 8i, PL/SQL, In-house Bug Tracking System

Worked on a Project for a Tele-Communications Research Organization.

Participated in the design and development of Network Management System. The System maintains and monitors the performance of various devices on a global network using proprietary protocols. The work involved designing and developing Class libraries for communicating between different processes by implementing Client/Server paradigm using sockets, message queues and semaphores.

Environment: C++, Sun, Oracle 8i


. NJ

Type: Permanent  
Location: NJ  
Availability: ASAP  
Salary/Rate: 60k  
Reference: 839