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Nair
System Analyst
Sarjen Systems Pvt. Ltd.
Ahmedabad, India.
Contact at: 09824673951/09428173935
shaini4ever@gmail.com
shaini4ever@yahoo.co.in
Executive Profile: Shaini Nair is dynamic, flexible and good team player having zeal to get
results with in stipulated time period & certain deadline. Shaini has one and half years of
experience with one of the fastest growing IT Company in the capacity of Software Professional.
She is good in User (Client) training, system analysis, User Requirement study, black box testing
and documentation part. Shaini who has pursued Master in Computer application do possess skills
such as analytical, communication, functional and client facing. Looking for the challenging role
with desire to work in entire gamut of SDLC with any reputed/well established organization across
the globe.
Task Accomplishment:
One of the member of the team, who has done all the assigned tasks related to SPL (Structured
Product Labeling) & eCTD (Electronic Common technical document) module during the US F.D.A.
approval as well as after the approval too. It has increased market value & brand equity of
particular product.
Successfully completed all the assigned tasks related to QMS (Quality Management System) &
Documentation before audit of Quality & validation, done by British representatives for the
Pharmacovigilance (PVNet) product. After completion of the audit, considerable validation
checklists and processes have been adopted by the organization to ensure the better quality of
product.
Successful & regular testing done before the live demonstration and application release at client
server, especially frequent changes and customization asked by the client. Demonstration of
customized applications & user training to current users and new prospects too. It provides ease
to customer before purchasing the application & further use of it in their system.
Achievements:
Got an opportunity of client interaction & On-site visit during training & probation period,
especially at the initial phase of career with the organization.
Got an opportunity out of 6 team members to represent organization at the time of “Quality and
Validation Audit”, done by British representative. Done quality management process, application
validations through validation standards such as: IQ (Installation qualification), OQ (Operation
qualification) and PQ (Performance qualification).
Got appreciation letter from HR department for the successful completion of annual event, held in
February 2009. Played role of coordinator & facilitator into the event.
Technical Platform:
Projects:
• Reporting to Project Manager with the team of 4 members by spending approximate work
tenure of 4 to 6 months on each above mentioned 3 projects
• Analysis of structure and specific format required by FDA
• Assisted the client to do the submission at FDA
• Maintenance of database in eCTD application
• Imparted demo of the application to make new clients
• Played active role in getting approval from FDA for the application
• Documentation and testing of eCTD application
• Played a key role in submission of SPL using the application, understanding all tags of it
and solving queries of client
• Database designing in PVNet application & training to new users documentation and
testing of application along with review of code in PVNet application
Pursued Bachelor of Computer application from Sardar Patel University obtaining second
Class in the year of June 2004.
Training attended:
Core Competencies:
Analytical skills, Communication skills, Technical skills, Client facing skills, Business Skills and
Team work with flexible attitude towards different situations
Personal details: