Project Ms Office

Curriculum Vitae

Monica Grover

Masters in Arts, English Literature

E-mail: **************@*****.***

WORK EXPERIENCE 5 YEARS 5 MONTHS

July 2010 to Jan 2011: Assistant Manager at Tata Consultancy Services

May 2006 to June 2010: Executive at Tata Consultancy Services

PROJECTS

Project: Decommissioning, Validation and Technical Writing for Legacy IT applications

Client: Eli Lilly and Company (USA)

Duration: Oct 2009 – Jan 2011

Tools: Documentum, REMEDY, MS Office 2007 and Eli Lilly Custom Developed Tools

Team Size: 6

Contribution:

• Involved in the Quality Compliance as part of Legacy Application Retirement

• Identified the Legal Hold Applications to ensure correct data migration

• Identified the risk levels of the applications to decide its retirement. Performing Risk Assessment for the systems

• Managed the Change Control Procedures for IT Applications in REMEDY

• Created the yearly Plan for retirement of systems (in consultation with Custodians and Owners) and driving the process to ensure timely elimination of low value assets from the inventory

• Developed validation plans, protocols, and reports

• Authored the Retirement Plans, Data Archival Plans, Retirement Reports for the regulated applications

• Authored Process Documents for the Application decommissioning

• Authored Best Practices for the team to effectively implement the project

• Authored Test Plans for Data migration to CAS (Repository)

• Involved in testing correct data migration.

• Approved these Quality documents as a Senior Quality Personnel

• Worked closely with CSQA to ensure that the GMP systems are fully compliant with CSV Policies and Procedures

• Conducted and approved Periodic Reviews of computer system validation documentation.

• SLA Monitoring, Service Levels (as defined and implemented) tracking and reporting to the client on a monthly basis

• Provided innovative solutions and drive Quality Systems initiatives for continuous improvement, regulatory compliance, exception management, and systems validation

Project: Validation and Technical Writing for the US Regulatory IT Applications

Client: Eli Lilly and Company

Duration: May 2008 to Sep 2009

Tools: Documentum, REMEDY, MS Office 2007

Team: 20

Contribution:

• Involved in Validation Planning including participating in Risk Assessment and SCAN Assessment

• Authored Periodic Review Reports to validate the IT applications

• Authored and Reviewed Test Plans for the enhancements to the application

• Analyzed change impacts in the periodic review reports and updated the associated documentation like Validation Plans, Risk Assessment, Design documents etc

• Developed/Approved the validation plans of new systems to ensure project go live

• Worked closely with CSQA to ensure that GMP systems are fully compliant with CSV Policies and Procedures

• Created the yearly Plan for retirement of systems (in consultation with System Owners) and drove the process to ensure timely elimination of low value assets from the inventory

• SLA Monitoring, Service Levels (as defined and implemented) recording, tracking, and reporting to the client on a monthly basis

• Developed/reviewed validation documentation

• Conducted Quality trainings for the internal team

• Conducted Effective Technical Writing trainings for the team

• Worked to complete the action items produced during the periodic review cycle

Project: Validation and Technical Writing for European Manufacturing Regulatory IT Applications

Client: Eli Lilly and Company

Duration: Oct 2007 to April 2008

Tools: Documentum, REMEDY, MS Office 2007

Team: 15

Contribution:

• Analyzed internal and external validation requirements

• Authored all the validation deliverables like Validation Plans, Risk Assessment Reports, Design, etc.

• Conducted Quality trainings for the internal team

• Conducted Effective Technical Writing trainings for the team

• Reported metrics for Quality Engineering and Validated systems as needed

• Accomplished Certificates of Compliance that ensure that all local SOP’s are in compliance with corporate policies and procedures

• Conducted meetings for Regulatory Impact Assessment and Validation Risk Assessment

• Authored Impact Assessment Reports to declare the complexity of the system

• Conducted Periodic Reviews of computer system validation documentation, including change control documentation to ensure that the validated state of a system has been maintained over time

• Developed/reviewed and approved validation protocols and final reports

• Represented Validation Services during sponsor audits and conduct external vendor audits

Project: DataBroker

Client: Bechtel Corp

Duration: Oct 2006 – Sep 2007

Tools: MS Office 2003, Irfan View, Snag IT, RoboHelp, Microsoft Visual SourceSafe 6, Adobe Acrobat 7.0

Team Size: 3

Contribution:

• Studied the system for setting up the SDLC documentation architecture

• Prepared work estimates and project plans

• Authored the user specifications for system enhancement/development

• Authored the online helps and user manuals using the Robohelp

• Updated the help files as per the change requests implemented for the application

• Identified inconsistencies and bugs in the application and existing documentation, and providing solutions

• Trained the team on the technical writing concepts, effective presentation skills and email etiquette

• Trained the Marketing Team of CMC on Proposal Writing

Project: ePC Works

Client: Bechtel Corp

Duration: May 2006 – Sep 2006

Tools: MS Office 2003, Irfan View, Snag IT, RoboHelp, Microsoft Visual SourceSafe 6, Adobe Acrobat 7.0

Team Size: 3

Contribution:

• Studied the system for setting up the SDLC documentation architecture

• Prepared work estimates and project plans

• Authored the user specifications for system enhancement/development

• Authored the online helps and user manuals using Robohelp

• Updating the help files as per the change requests implemented for the application

• Identified inconsistencies and bugs in the application and existing documentation, and provided solutions

• Trained the team on the technical writing concepts

• Drafted Training material on subjects like, Effective Presentation Skills, Email-Etiquette, Proposal Writing, Communication Skills

Project: Content Development

Client: Modern Publications (New Delhi)

Duration: Aug 2005 – Apr 2006

Tools: MS Office 2003 and Snag IT

Team Size: 2

Contribution:

• Edited the content for grammar, language and sentence structuring errors

• Conceptualized and proposed new and innovative ideas for the book covers

• Interacted with subject matter experts to draft the content

• Created new content for books used by students at the school level

• Developed exercises and tutorials per school standards

EDUCATION

PROFESSIONAL DEGREES:

Masters in Arts, English Literature, year 2005

Hansraj College, Delhi University, New Delhi (5 yrs program)

TRAININGS CONDUCTED

• Effective Technical Writing

• Email Etiquettes

• Writing Effective Presentation

• Communication Skills

• Proposal Writing

SKILLS/COMPETENCIES

Software and Tools

MS-Office 2003 and 2007, RoboHelp X5, SnagIt, Irfan View, Adobe Acrobat 7.0, Microsoft Visual SourceSafe 6, Microsoft Visio, Webtop Documentum, REMEDY

Languages

English: Spoken, Read, Written

Hindi: Spoken, Read, Written

WORK PERMIT

Require sponsorship/H1 B visa as work permit

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