SUMMARY:

• Work in a progressively growing organization, which shall able to utilize my education, skills and Experience.
• 12.5 year experience in IT & pharmaceutical industry, software development, support Confidential and IT validation.

TECHNICAL SKILLS:

IT Validation: 21 CFR Part 11,ERES,GAMP5,,GCP,GXP,Software Life cycle,IO,OQ,PQ,SRC

Languages: VB6.0,C setup making, Deployment

DBMS / RDBMS: Oracle 9i, SQL Server2000/2005, MYSQL

SERVERS: IBM Xeon 3200 M2 series, IBM Xeon 3400 Series SERVR.

Operating System: Win7, XP Professional SP2,Window Server2000

Window Server 2003.:

Report tool: Work on Crystal report 8.5,Excel 2007 - 2003

Others: Security cam’s installation, I-net. RS 232 PORT communication With VB6, Data communication, Work on C Hitek Compiler. System Installation.

PROFESSIONAL EXPERIENCE:

Developer and Test Lead

Confidential

Responsibilities:

• Creation of data fields, grids, Workflow, Group Categories, User roles, Complete System configuration.
• Config form design, Desktop Layouts
• Configure Workflow, system configuration classes, notification template, notification classes.
• Validation documents: - Preparation of FRS, DS, Config IQ of SCAR,CAPA system.
• Test Lead experience on CAPA, SCAR with Stratas Quality Management system workflow. Development of test cases for OQ, Generating and executing OQ protocol in Val Genesis Tool.
• Testing experience of newly design process workflow like CAPA, Change management(Change control),Audit,Deviation,Complaints,Complicance,Artwork,,OOS, OOT etc. in development server. Design and develops different pubs and query in the system.
• Track Wise provides the unique capability to manage all issues, actions, and changes in a centralized and integrated system without requiring separate ‘modules’.
• Automated workflow and configurable business rules ensure processes are followed, while enterprise reporting provides reliable information upon request to support decision-making and improve cycle times.­­
• PR import process, configure track wise query ,configure new fields,workflow,crystal reports.
• Create,update,delete id’s in production server of Confidential sytem,assign role and responsibilities to user .
• With compliance document of each id .assigning proxy to user’s, identify inactive users to make license free.
• Give training on Confidential system to new users.
• Update in QA requested Record’s according to requested reference.
• Can help on making crystal reports on different requirements.
• Configuration Support
• SMTP support configuration Migration Support selection value Migration support
• PR import for new record's
• PR imports for existing records
• User access new, update in PRD testing of new workflows
• Writing Qualification scripts for trackside
• Execution Qualification scripts for Dev, QA and PROD
• Execution and maintenance of data backups
• Execution of views for new system

Confidential

Software Developer

Responsibilities:

• I am responsible for maintaining User accounts(Add,Update,delete),Assigning Scope, assigning user roles.
• Testing of newly design workflow (CAPA, CCR, Investigation, GSC), Responsible for day to day support.
• Providing L1 and L2 support to business users, and Assigning proxy to the user, coordination link between business user and Confidential development L3 team for changes and implementation. .

Confidential

Software Developer

Responsibilities:

• Complete learning and training system for a regulatory company.
• Support’s for online training, SOP, creation Classes, making questionnaires, reports etc.
• Part of team for currently ongoing implementation of novatek global stability system in Confidential laboratories limited, making compliance document, risk analysis perform training ‘s of all user, making strategy for implementation of system in DF and API division.
• Reviewing the complete qualification SDLC with risk assessment SLRA FLRA of IT systems.
• Reviewer test scripts for OQ, PQ qualification of WPP- ESB-SAP integration systems.
• Technically able for driving IT validations of GXP and non-GXP systems, Preparing the complete qualification SDLC with risk assessment SLRA FLRA of IT systems.
• Developed test scripts for IQ, OQ, PQ qualification of servers - Client software.
• Develop validation scripts IQ, OQ, PQ. CCR, GXP analysis, URS, FRS, PVP, Vendor audit/survey, risk analysis SLRA, FLRA, SDS, VSR, RTM, CSD, CMD, SRC.
• Team member of Qualification IT system from change control, SDLC up to qualified Software release in production environment. Provide document support while having internal and external audits.
• Application system for tablet block where HMI machine are in production( like bottle unscrambler,Disicant pouch inserter, In line capper,Cotton machine, Canester Inserter,Wruster Granulator, Wruster Coating Granulator,Fluid Bed Equipment,Rapid Mixer Granulator,V blender, Coating machines, Capsule filling machine, Tablet compression machine,Vaccum Tray Dryer, Retorqer).
• These machine display data on HMI and print reports individually.
• We develop intranet to capture data from these machines and store in to historian database server,Our software application developed in VB,SQL 2005 Reporting tool generate reports (as required by online BPR).which generates data reports from given time period, batch wise, Included value parameter’s Set, actual, batch number, operator detail .
• Basically software is reporting tool Working centralized individual HMI data to data base and generate reports (as required in BPR).
• Application system is developed for Packaging lab Confidential laboratories.
• Using instrument cognex dm100 analyst can read values from carton’s, packages, vials these values matched with master’s and vendor given sheets.
• On the basis of matching values master’s cartons and vendor printed cartons sheets report printed and submit to QA.
• Same time this record with batch number, material code is saved to data base for future reference.
• Complete IT compliance document developed according to GAMP5, 21 cfr is done. Application developed in SQL 2005,VB.

Environment: VB.net 2005, VB6.0,ASP,ORACLE 9i,crystel report 8.5

Confidential

Software Engineer

Responsibilities:

• Training for toll Software, Sift Software Planning, supervise Initial installation of HardwareNetwork. And installation Of Software.
• Managing Database in Head Office of Different Confidential ’s. Taking Reports
• And submit to Director manage Software Team. R & D On newly required Equipments of Electronics and Software’s.

Environment: VB.net 2005, Sql2000