Project Manager Crystal Reports

Location:

India

Posted:

November 16, 2012

Contact this candidate

Resume:

Venkata Reddy G

E-Mail: ********@*****.***

Mobile No.: +91-988**-*****

Experience Summary

. 9+ Years of experience in Software Application Development, Maintenance,

Support, Customization of Products and Validation

. Rich experience in developing products for Health Care, Clinical,

Pharmaceutical, Caterpillar Machines and Agriculture Laboratories

. Working extensively in Studying, Analyzing, Designing, Developing,

Deploying, Training, Implementing and maintaining Laboratory Information

Management System (LIMS) system

. Well versed with LabWare LIMS V5 & V6, Caliber LIMS, MS Access, SQL

Server, Oracle and Crystal Reports

. Working in all the phases of Software Development Life Cycle such as

Requirements gathering, Analysis, Design, Implementation, Testing and

Deployment.

. Excellent work experience in Laboratory Business Processes with sound

knowledge of the Regulatory Norms as in FDA regulated environment

. Experience in integration with Instruments, SAP & Empower with LIMS

. Excellent knowledge in writing LIMS Basic code

. Excellent working knowledge of GxP (GMP, GLP, GDP, GAMP and 21 CFR Part

11) as they relate to Computer Systems Validation

. Hands-on Validation, Testing experience in IT systems and Empower System

. Well experience in Validating LabWare modules

. Well experience with Computer System Validation (CSV) and Software Change

Controls

. Participated in Testing activities such as Installation Qualification

(IQ), Operation Qualification (OQ) and Performance Qualification (PQ)

necessary in Pharmaceutical Software

. Well experience in writing SOPs

. Onsite visit to Spain and USA

Technical Skills

Operating Systems: Win

2000, Win XP

. Programming Languages: ASP, ASP.NET, VB, VB.NET, Java Script, VB

Script, VML, CSS, HTML, C#, LIMS Basic

. Databases: Oracle, MS SQL Server 2000, MS Access

. Application Tools: LabWare LIMS, Caliber LIMS

. Web Related: JavaScript, VBScript

. GUI: Visual Studio 6.0

. Other Packages: Visual Interdev 6.0, Visual Studio .Net,

Microsoft Visio 2002, MS Office, Crystal Reports

Education Profile

. Degree of Master of Science (M. Sc Computer Science) from Sri

Venkateswara University, Sep' 2001

. Degree of Bachelor of Science (B. Sc Computer Science) from Sri

Venkateswara University, Apr' 1998

Working Experience

. Working with HCL Technologies Ltd, as Associate Project Manager (LIMS

Projects) from May'2011 to Till Date

. Worked with TATA Consultancy Services Ltd, as LIMS Consultant from

Feb'2010 to Apr'2011

. Worked with Satyam Computer Services Ltd, as LIMS Consultant from

Dec'2006 to Oct'2008

. Worked with LabWare Limited as LIMS Specialist from Jan'2005 to

Nov'2006

. Worked with Caliber Technologies Pvt. Ltd, as Senior Software Engineer

from Jan'2002 to Dec'2004

HCL Technologies Ltd., - Projects Profile

Client: Merck, USA

Project Description:

Merck having various research laboratories across the globe, wanted to

implement Tier 3 requirements in the existing Research LIMS (RLIMS)

application

Understanding the Business and Technical goals of the initiative with a

detailed analysis of the requirements shared by Merck

Roles and Responsibilities

As the Associate Project Manager (LIMS Consultant), is responsible for

. As LIMS Project manager for Merck responsible for Planning and

strategize of projects

. Responsible project estimation and resource planning towards successful

completion of the project.

. Taking care of the other LIMS support applications such as ELN, Empower,

Nuclear LIMS

. Understanding of the Merck existing Research LIMS (RLIMS) application

. Design and Development of Tier 3 enhancements

. Preparing High Level Design diagrams of Tier3 enhancements

. Developing code according to the Tier3 enhancements

. Preparing Training documents for the users

. Gather requirements from client Merck located in US, UK and China.

. Planning the resources and budgeting for projects.

. Review of business requirements and technical specification

. Managing of Technical Analysts and developers

. Training giving to the end users

. Handling support cases of Medium & High, responding specified time

. Helping team in resolving critical cases if required

Tier 3 Enhancements are to be implemented in the following areas of RLIMS:

. Product Specifications

. Lot Manager

. Folder Manger

. Inventory Manager

. Stability Manager

. Approval Manager

. Instrument Manager

. eRequests

. Data collection from Empower

Environment: LabWare LIMS V6, Crystal Reports, ICA Citrix Client, SQL,

TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS 6.0, Oracle and Crystal Reports

CLIENT: BOEHRINGER INGELHEIM ROXANE INC.(BIRI), USA

Project Description:

BIRI having various pharma laboratories across the globe, wanted to develop

new COA Approval Functionality & Development of COA Reports in existing

LabWare LIMS application

Understanding the Business and Technical goals of the initiative with a

detailed analysis of the requirements shared by BIRI

The Process and Requirement of the Laboratories is studying at the BIRI

site

Roles and Responsibilities

As the Associate Project Manager, was responsible for

. Understanding of COA reports requirements

. Architecture of Reports development

. Estimation each requirements of COA reports development

. Prepared detailed Project Plan

. Prepared High Level Design diagrams

. Prepared Training documents for the users

. Training given to the end users

. Performed Validation on COA reports according to FDA regularity

Environment: LabWare LIMS V6, Crystal Reports, ICA Citrix Client, SQL,

TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS 6.0, Oracle and Crystal Reports

TATA CONSULTANCY SERVICES LTD., - PROJECTS PROFILE

Client: Covance, USA

Project Description

Covance is one of the world's largest and most comprehensive drug

development services companies with more than 11,000 employees in 60

countries. Through its nonclinical, clinical and commercialization

services, Covance has helped pharmaceutical and biotech companies develop

one-third of all prescription medicines in the market today.

They wanted to implement Bio-analytical & Toxicology reports to view the

status of the pre-clinical & post clinical testing on animals

Roles and Responsibilities

As the Crystal Reports Developer, was responsible for

. Studying Functional Requirements of the Covance Laboratories

. Developing Crystal Reports

. Performance tuning for the reports

. Writing Test Scripts according to the Functional Requirements

. Writing/Reviewing Functional Verification scripts according to the

Requirements

. Preparing System test cases

. Crystal reports integration with Business Objects (BO) Server

. Organizing Weekly Status Call meetings with Onsite and Offshore team

. Performed Computer System Validation

Satyam Computer Services Ltd., - Projects Profile

Client: Caterpillar (CAT), USA

Project Description:

CAT having various testing laboratories across the globe, wanted to

implement a LIMS system in all the major laboratories.

The Process and Requirement of the Laboratories was studied at the CAT

site.

The design of the to-be system was developed and the LabWare LIMS system

modified as per the requirement and implemented the laboratory.

The users were trained as per the requirements of the laboratory, LIMS and

as per their authority levels.

Roles and Responsibilities

As the Project Lead, was responsible for

. Configure and Customize Sample Management, Results entry, Results,

Schedulers review using Standard out of the box and customizing using

LIMS Basic.

. Used LIMS Basic Functions, Event triggers to customize user requirements

such as prompt for Audit Reason, Scheduler, Reactivate sample, Mail

Report, Add samples to Lot, Add tests to Batch etc..

. Load and create static data such as Analysis, components, Product

Specifications, Project Templates, Folder templates.

. Implemented and designed user security using roles, groups to authorize,

reject samples in sample review.

. Designed the architecture of LIMS Data model and extensive Hands on

experience in modifying table master and adding custom columns and

creating forms for data population.

. Define Time intervals in time point table and sell the concept to the

user community to align their business to the LabWare core functionality

. Trouble shooting performance issues and complex process workflows such as

calculations, reports, status rules etc.

. Coding and configuring the system using User security, Roles, Sampling

plan, Access Routines, Query Tags, Approval Manager and Reporting using

Crystal reports as per the requirement to meet Quality standards.

. Review, analyze, and evaluate existing business systems and corresponding

user needs.

. Write detailed description of user needs, program functions, and steps

required to develop or modify applications. Work with end users and

clients to evaluate and solve technical problems.

. Provide documentation to describe program development, logic, coding, and

corrections.

. Critically evaluate custom developed modules for completeness, accuracy,

and reliability.

. Work with the business areas and clients to understand their business

needs, analyzing the requirements and processes and making

recommendations on the optimal systems implementation of those processes.

. Develop a validation work plan with a team and execute successfully to

that plan

. Ability to perform workflow data analysis, gather requirement, data

mapping, and participate in system design, development and testing.

. Performing analysis of information and completing documentation of

complex business processes using Microsoft Visio.

. Obtaining client approval for documentation of current state and future

state business process documentation.

. Identifying gaps between current and future state business processes for

customization of software.

. Presenting process analysis and process improvement solutions to senior

management.

. Documenting LIMS application and compiling help file using third party

tools and integrating into the application. Transfer level 1 and Level 2

knowledge transfer to the team and help them to support the system after

go-live.

. Developing user and detailed technical documentation for software

application and database.

. Lead the architecture and design efforts to clearly outline the product

design strategy, define all external dependencies, and provide clear

direction for development efforts.

. Develop requirements, specifications, design changes, enhancements,

maintenance and testing to new and modified application systems, ensuring

a quality product is delivered and achieves business objectives.

. Support the development, implementation, enhancement, maintenance,

Production Support and documentation of application systems, application

modules, and subprograms.

. Performed Computer System Validation

Environment: LabWare LIMS, Crystal Reports Windows 2000/XP, ICA Citrix

Client, SQL, TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS, Oracle, ICA Citrix client and Crystal Reports.

CLIENT: PFIZER PHARMACEUTICALS, USA

ROLES AND RESPONSIBILITIES

As the Project Lead, was responsible for

. Studying Functional Requirements of the Pfizer Laboratories

. Writing Test Scripts as per the Functional Requirements

. Developing functionality and designing Crystal Reports

. Worked on Stability, Non Stability modules.

. Writing/Reviewing System Test Plan (Development Test Plan) according to

the Requirement Specification.

. Writing/Reviewing Functional Verification scripts according to the

Requirements.

. Performed Administrator duties.

. Build and Configure Static and Dynamic data.

. Generating Reports and validating data and format.

. Prepared/Reviewed System test cases

. Writing/Reviewing Test Summary Reports and SOPs

. Organized Weekly Status Call meetings with Onsite and Offshore team.

. Supporting Function Verification for Change Controls.

. Done version update from 5.0 to 6.0

. Performed Computer System Validation

Environment: LabWare LIMS, Crystal Reports Windows 2000/XP, ICA Citrix

Client, SQL, TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS, Oracle, ICA Citrix client and Crystal Reports.

LabWare Limited., - Projects Profile

Client: Mitsubishi Chemicals Corporation PTA India Corporation Private Ltd

(MCPI), India

Project Description

MCPI having various testing laboratories across the globe, wanted to

implement a LIMS system in all the major laboratories.

The Process and Requirement of the Laboratories was studied at the MCPI

site.

The design of the to-be system was developed and the LabWare LIMS system

modified as per the requirement and implemented the laboratory.

The users were trained as per the requirements of the laboratory, LIMS and

as per their authority levels.

Roles and Responsibilities:

As the Project Lead, was responsible for

Gathering Functional Requirements of the MCPI Laboratories.

Designing the database structure required for the system.

Design SQL Server database for Project.

Developing the prototype of the to-be system and present the same to the

users for validating the business solution suggested meeting the

requirements.

Designing the Crystal Reports as per the Functional Requirements.

Performed Computer System Validation

Environment: LabWare LIMS, Crystal Reports Windows 2000/XP, ICA Citrix

Client, SQL, TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS, Oracle and Crystal Reports.

Client: Eastern Health Shared Services (EHSS), Dublin

Project Description

EHSS, the largest health services company, having various testing

laboratories across the globe, wanted to implement a LIMS system in all the

major laboratories.

The Process and Requirement of the Microbiology and testing Laboratories

was studied at the EHSS site.

The design of the to-be system was developed and the LabWare LIMS system

modified as per the requirement and implemented the laboratory.

Roles and Responsibilities

As the backup project lead, was responsible for

Gathering the Functional Requirements of the EHSS.

Designing the database structure required for the system.

Designing the Crystal Reports as per the Functional Requirements.

Environment: LabWare LIMS, Crystal Reports Windows 2000/XP, ICA Citrix

Client, SQL, TOAD, Visio, Word, Excel.

Tools used: LabWare LIMS, Oracle and Crystal Reports.

Client: Automated Testing for LabWare LIMS

Project Description

Writing subroutines to test LabWare LIMS Functionality

Roles and Responsibilities

As the team lead, was responsible for

Writing LIMS Basic code and coordinate development team

Caliber Technologies Pvt. Ltd., - Projects Profile

Client: Dr. Reddy's Laboratories, India

Project Description

. Caliber LIMS is an automation product for the activities in an

Analytical laboratory which could be different and many. The laboratory

could be involved with sample analysis tasks for both internal

(departments) and external customers. During the course of analysis and

sample allotment, test readings and observations entry, results

calculations based on the test readings and observations and applicable

formulae, sample approvals and other related information. It also gives

option to user to store specific result directly into user database.

Roles and Responsibilities

As the Team member, was responsible for

Programming, Unit Testing, User Acceptance Testing

Visited client places for Support

Participated in testing activities such as IQ (Installation Qualification),

OQ (Operation Qualification) and PQ (Performance Qualification) necessary

for Pharmaceutical.

Performed Computer System Validation

Environment: Caliber LIMS, Crystal Reports Windows 2000/XP, TOAD, Visio,

Word, Excel, .Net, Active Server Pages 3.0.

Tools used: Caliber LIMS, Crystal Reports Windows 2000/XP, TOAD, Visio,

Word, Excel, .Net, Active Server Pages 3.0.

CLIENT: AUROBINDO PHARMACY, INDIA