Resume ganesh empower_CDS

1. Ganesh Panjaksharam
66 E Cliff Street,
Apt 7,
Somerville
New Jersey
08876.
E-Mail: ganesh.panjaksharam@cognizant.com,
ganeshvijan03@gmail.com.
Mobile: +1-908-392-5932
Objective
To seek a good position in your company to show my talent and apply my knowledge and skills
in cutting edge assignments and contribute myself towards company’s growth and self.
Executive Profile
Overall experience of more than 7 years. Currently working on Cognizant Technologies Solutions
(Dec 2013- Till date) supported Amgen, Sanofi.
 Working experience in R&DI and manufacturing under Pharma domain.
 Extensive experience in Empower, Labware LIMS.
 Extensive experience in Empower CDS 2 & 3 versions, NuGenesis SDMS support
& maintenance.
 Work/troubleshooting experience with Waters instruments, Aglient GC and HPLCs.
 Troubleshooting of LACe boxes.
 Knowledge on ICOP, ICS drivers, verify file check, patch installation in Empower.
 Working with Vendor Waters for troubleshooting.
 Change Management, incident, problem management, downtime notifications.
 Worked in highly regulated system, GxP (GLP, GCP, GDP, GMP) validated system.
 Performed IQ, OQ PQ and validation system testing and test script execution in
ALM.
 Good work experience with Creation of test case, test scenarios, execution of test
cases and creating test script/templates.
 Used testing tools like ALM, Bugzilla.
 Communication cable RS232, IEEE, Ethernet and bus LACE cord interface.
 Cold/Hot backup, Backup restoration of databases
 Import/Export, Refreshes.
 Perform daily incremental backup and full weekly backup using Oracle backup.
 Monitors database activity and file usage, and ensures necessary resources are
present so that databases function properly by removing or deleting old or obsolete
files.
 Good knowledge in 21 CFR part 11 and worked in a compliance environment.
 Work experience with Chromeleon upgrade to higher version, Chromeleon
application ownership for server relocation, Issues on Chromeleon front-end and

2. back-end, and its various implementations. Instrument configuration with Agilent
HPLC and GC.
 Work experience in citrix and service provider teams like windows, database, citrix
team for project co-ordination.
 SDMS Vendor Waters certified.
 Requirement gathering, Client interaction, Requirement and Design Documentation
ownership.
 Working with IBM Cognos tool to pull the records for Change Management,
Problem Management.
 Using MIDAS tool, EDM quality for uploading and routing the GxP related
documents for approval for FDA audit.
 Highly proficient in Microsoft Office suite of products - Excel, Word and
PowerPoint.
Roles Performed in Empower 2 & 3 Version:
Empower system ownership end-end activities.
Troubleshooting of LACe boxes.
Validation of system with verify file check of ICOP, ICS versions.
User group, user type, user creations.
Empower node creation, Configure DHCP, System audit trial backup.
Project restore/backup, hot/cold backup, creation of templates.
MsPatch installation with Luminous tool.
Change Management, incident, problem management, downtime notifications.
Professional Summary
Client Employer Role Environment
Sanofi Aventis
Cognizant
Technologies Solution
(CTS)
Associate
Requirement gathering,
Documentation, Client
Interaction.
Amgen Inc.
Cognizant
Technologies Solution
(CTS)
Associate
Empower CDS 2&3,
NuGenesis
Trained with
Baxter and
Novartis
Wipro Technologies Senior Executive LIMS, Empower
Merck HCL Technologies Software Engineer Empower CDS

3. Project Description
Sanofi- It engages in the research and development, manufacturing and marketing of
pharmaceutical drugs principally in the prescription market, but the firm also develops over-the-
counter medication. The company covers seven major therapeutic areas: cardiovascular, central
nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines (it is the world's
largest producer of the latter through its subsidiary.
Amgen –A biotechnology company, where it is committed to unlocking the potential of biology
for patients suffering from serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and understand the fundamentals of human
biology.
Merck Sharpe & Dohme – One of the largest pharmaceutical company manufacturing Drugs and
Medicines. I have been part of MMD Global for Support and maintenance process. LIMS is a
Laboratory Information Management System used for Sample processing, testing and result entry.
It is used globally with more than 5,000 users.
Roles and Responsibilities
 Playing the lead role in the current company, taking care of the lab support application and
managing the team as well.
 Working in high regulated impact applications, where strictly process follow ups trainings are
being conducted and have educated team as well.
 Both process and technical wise have educated the team.
 Analyzing and providing the fix for the users on their requirements in a timely manner.
 Monitor the application servers and services and troubleshooting.
 Restore GxP data to the users to avoid business impact.
 Perform application testing on migration following GxP standards.
 Client facing, present system status reports to clients on weekly basis.
 Track system performance annually, capture deviations and implement fix to achieve stability.
Technical Profile
Operating Systems Windows XP, 7
RDBMS Oracle
Tools Remedy, Crystal reports, Service now, EDM quality, IBM Cognos tools.
Achievements
Certifications
1 Waters Certifications from Vendor for NuGenesis SDMS.
2 FTL (First Time Lead) Certified
3 RTB (Run the Business) Certified.

4. Trainings
1 Admin 20 training on Labware LIMS
2 Completed Level I and Level II Pharma
3 GxP related trainings
Declaration
I hereby declare that all the information furnished above is true to the best of my knowledge.
DATE: Yours truly,
PLACE: New Jersey, US P. Ganesh