October 9th, 2010, 12:53 PM
Post Count Number #1
www.heliosmatheson.com Helios and Matheson Information Technology Ltd Chennai : Programmer Analyst
Programmer Analyst:
Qualification: Bachelor's Degree in Computer Science, CIS, Math or Engineer (Any Branch);
Experience 2 years and above
if interested, please send resume to
Attn: HR Dept.,
The Laxmi Group,
Inc. 4699 Old Ironsides Dr,
Suite #100, Santa Clara,
CA 95054.
About Us:
Commencing operations in 1991, helios and matheson has helped scores of clients maximize the performance of their IT organizations with a powerful suite of services driven by a seamless global delivery model. we are headquartered in chennai, india with offices and subsidiaries in usa, singapore and india. Over time we have built a strong USA and european presence and deep client relationships. Sustained infrastructure and sales/marketing investments over the last 20 years have helped create a world-class knowledge-networked work environment that empowers our team to provide high quality solutions to clients.
Contact Us:
Helios and Matheson Information Technology Ltd
Ganga griha, No 9, (old #6-d),
Nungambakkam High Road
Chennai 600 034 Tamilnadu India
Phone : +91-44-4391 0000
Fax : +91-44-4391 0099
Email : career@heliosmatheson.com
Website:www.heliosmatheson.com
Last edited by Guest-IJT; July 22nd, 2011 at 07:29 PM.
July 22nd, 2011, 07:29 PM
Post Count Number #2
IJT addict
Name : Suhas NAik
Email : isuhasnaik AT yahoo.co.in
Designation / Skillset : QA
Resume :
Suhas Naik
Professional Summary
Suhas has around four years of experience in the IT industry specifically in the Life Sciences Domain. Has 4 years of experience in providing solutions in the Quality and Regulatory area by implementing TrackWise. TrackWise is a QMS (Quality management system) developed by Sparta Systems. Suhas has been majorly involved in Designing workflows, Configuring and Supporting TrackWise adhering to FDA regulations and 21 CFR Part 11. Worked closely with QA representatives to understand the complete QA processes and automate the same.
Worked with major Pharmaceutical clients like Merck & Co, Schering Plough and GE – Health Care. He has extensive process knowledge in areas like Audits, handling customer complaints, AER(Adverse Event Reporting), CAPA etc and has implemented the same using TrackWise. Also has strong technical knowledge in SQL and Crystal Reports.
Also involved in handling Computer System Validation projects in line with FDA compliance.
Education
Degree University Year of Passing
B.E (I.T) VTU (Vishveshvaraya Technological University) (06/2007)
PUC GSS Collage, Belgaum (05/2003)
Certifications
- Microsoft Certified Technology Specialist (MCTS).
- Microsoft Certified Programmer - .NET Framework 2.0 Web Applications (MCP).
Experience
Organization Designation Duration
Satyam Computer Services Ltd., TrackWise Consultant (Dec/2010) – Till date
HCL Technologies Software Engineer (Aug/2007) – (Dec/2010)
Technical Skills
Operating Systems Windows 9x, Windows NT
Languages C#.Net, Visual Basic
Databases Oracle 9i, 10g
GUI TrackWise
Case Tools TrackWise
Web Related IIS
Tools & Utilities TrackWise, Crystal Reports, StarLIMS
Domain Knowledge Life Science
Projects Developed Audit Management, CAPA, AER, Customer Complaints, Computer System Validation
Trainings
Sl# Title Location Organized by Duration
1 Oracle 9i Chennai HCL Technologies. 8 Week
2 TrackWise Chennai HCL Technologies 5 Weeks
3 Pharma Domain Chennai HCL Technologies 7 Week
4 21 CFR Part 11 Chennai HCL Technologies 1 Week
5 Change Control Management Chennai Merck & Co. 2 Day
6 Problem Management Chennai Merck & Co. 2 Day
7 Incident Management Chennai Merck & Co. 2 Day
8 Defect Management Chennai HCL Technologies 2 Day
9 Configuration Management Chennai HCL Technologies 2 Day
10 Six Sigma Green Belt Hyderabad Mahindra Satyam 2 Days
11 ITSM Hyderabad Mahindra Satyam 2 Weeks
12 CDS - Chromatography Data Systems Hyderabad Mahindra Satyam 1 Week
13 STARLIMS Hyderabad Mahindra Satyam 1 Week
Projects Profile
1. Project Name : TrackWise PoC
Client Mahindra Satyam internal
Role Project Lead
Organization Satyam Computer Services Limited, India
Duration (Jan/2011) – (Apr/2011)
Team Size : 5 Project : TrackWise PoC Module : Audit Management
Environment
(with skill versions) Software
Languages : Java
Database : Oracle 9i
Tools : TrackWise, Crystal Reports, SQL
O/s : Windows XP
Hardware Standard Pentium Dual Core systems
Project Description
This project was done as a Proof of Concept internally in Mahindra Satyam. A complete Audit Management system was built using TrackWise, Oracle 10g and Crystal Reports 11. The requirements were gathered in real time from the requirement document issued by one of the clients - GSK (Glaxo Smith Kline). Based on these requirements workflows were designed and configured using TrackWise. This project demonstrated an end to end implementation of Audit Management System and the complete functionality of TrackWise.
Contribution
As a Project Lead, was responsible for
- Analysis of the Requirement Document provided by the client
- Training a team of 4 on TrackWise and Crystal reports.
- Involved in assigning tasks to the team members, monitoring performance and also mentoring them.
- Designing the project plan and adhering to the same
- Designing Workflows
- Installation of TrackWise and creating a database server.
- Configuration and Validation of TrackWise
- Development of Crystal Reports
- Database management and JDBC connectivity
- Testing - unit testing & integration testing
- Maintaining Documentation
- Responsible for overseeing the Quality procedures related to the project.
2. Project Name : MMD
Client Merck & Co
Role Software Engineer
Organization HCL Technologies, India
Duration (Aug/2007) – (Dec/2010)
Team Size : 5 Project : MMD Quality & Regulatory Module : Audit Management,
Customer Complaints,
Bio Sterile Validation,
Batch Record Tracking,
ITS(Tender Management),
Change Control Management,
CAPA
Environment
(with skill versions) Software
Languages : Java
Database : Oracle 9i
Tools : TrackWise, Crystal Reports, SQL
O/s : Windows XP
Hardware Standard Pentium Dual Core systems
Project Description
Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck Manufacturing Division is using TrackWise Product to cater Quality, GMP and Regulatory requirements. All the TrackWise related activities like Configuration/Validation/support was handled by HCL.
Contribution
As a Software Engineer, was responsible for
- Understanding the Client’s Business and Processes.
- Developing software solutions in line with 21 CFR Part 11
- Configuring Workflows in TrackWise
- Configuration and Support Activities of TrackWise.
- Designing Reports using Crystal Reports and integrating with TrackWise.
- Using TrackWise Coordinator Utility to automate scheduled processes.
- Leading a team of two to provide production support to 8 regulatory applications
- Extensive use of Microsoft technologies like VB 6.0 and C# .Net.
- Analyzing and resolving the emergency production issues.
- Involve in the analysis and technical discussion with the clients for their Product suite.
- Designing and developing for the business enhancements.
- Writing test cases and involve in Unit testing.
- Involves in the Deployment of the new applications into the production environment.
- Understand the client’s requirement and gaps, thoroughly to provide the best service in development and implementation of forthcoming versions.
- Be familiar with platforms and enhancements of the Client.
- Prepare application, technical & functional design documents as per the client’s requirements.
- Experienced in Software project development based on the processes in line with SEI CMM Level 5 standards.
- Handle problem tickets, user queries and service requests.
- Handle the application’s change requests.
- Conduct self and peer reviews to ensure the quality of the deliverables.
- Coordinate production release tasks.
- Respond to clarification requests and issues from the team.
- Retrospective and Repetitive validation
- Preparing Validation documents like IQ/OQ/PQ, validation plan, test cases, risk assessment etc.
QA Process knowledge :
- Change Control Management
- GMP Documentation
- Writing SOP’s
- Deviation Reporting
- Product Identification and Tracebility
- Product Complaint Handling
- GMP Training and keeping records
- Quality Investigation Process
- Cross Functional Investigation
- Vendor Management
- Master GMP documentation
Other experience :
Worked closely with Pre-Sales team to capture TrackWise opportunities from clients like GE-Healthcare, GSK (Glaxo Smith Klien) and Verion. Responded to RFP’s.
Contributions :
- Analyze RFP’s
- Respond to RFP’s
- Create Presentations
- Estimations
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4371396
Date & Time : 14th Jul 2011 4:05 PM (UTC)
IP Address : 14.96.87.129
Browser Info : Mozilla/5.0 (Windows NT 5.1) AppleWebKit/534.30 (KHTML, like Gecko) Chrome/12.0.742.112 Safari/534.30
Predicted Country : --