CV

1. SABYASACHI MITRA
Arya Elegance, Flat No-101, Narayan Nagar 3rd
Block, Bangalore-560062
98322448219614995003mitra.sabyasachi@gmail.com
Date of Birth - 24 December 1981
OBJECTIVE
Seekingachallengingandrewardingopportunity withanorganizationof reputewhichrecognizes my true
potential and effectively utilizes, nurtures my excellent analytical and technical skills.
Experience Summary
Overall 10 years’ experience in the field software development, Quality Assurance, automation testing
ensures regulatory compliance as per 21 CFR Part 11, Annex11, GAMP5 and other guidelines. Presently
working as Sr. Associate IT-QA, Mylan Laboratories Limited, Bangalore.
Skills and Responsibilities
 Selenium automation using Robot framework on Java
 Well acquainted with Software Development Life Cycle.
 Implementation / Improvements of QA methodologies and product development. Prepare Test
Strategy document; identify test scenarios based on product design and expected functionality and
ensure exhaustive test coverage
 Basic knowledge on Selenium automation.
 Excellent knowledge on Web based Application, Mobile native apps and Product testing.
 Knowledge of testing in Web/Desktop applications, Restful API testing, Mobile & Tablet application
manually.
 Creating test data required for testing.
 Executed verification test procedures during formal verification of product
 Writing end to end test case and test Report
 Basic knowledge of Selenium ide .
 Basic knowledge of shell scripting
 Contribution towards root cause analysis of software defects reported and ensures that appropriate
fixes are verified properly and delivered in upcoming releases.
 Well acquainted with Software Development Life Cycle with strong logical and
 Debugging and problem solving skills.
 Good Exposure onRegulatoryrequirements of Computerized Systems and sound knowledge of GxP,
GAMP, EU Annex 11 and USFDA 21 CFR Part 11.
 Responsible for cite CSV SOP including creation, review and approval of the electronic data system.
 Support all audit and compliance related activities to the IT system at the site.

2.  Implementationof life cycle methodology(concept,planning,design, testing, Operation, retirement)
and assess Computerized Systems based on criticality and complexityInvolved in all the user access
control and password management activates in Mylan.
 Document preparation and execution like initial protocols & reports for IQ, OQ, PQ & RQ, other
validationdeliverables(SRS, IRA,URS, GAP Assessment,RiskAssessment,ValidationReport,Traceability
Matrix, Summary reports etc.)
 Versatile hands on Expertise in Computerized System Validation on all varieties of Computerized
Systemswhichincludes,butnot limited to Enterprise Computerized Systems, laboratory Standalone
Computerized Systems, Automated Process control systems, CDS and Excel sheets.
 ValidatedAutomatedProcesscontrol systems like PLC and HMI, controlled, liquid and powder filling
line equipment's, Automatic Sticker labelling Machine, Automatic multi box and packaging systems
etc.
 Responsible for end to end Computer System Validation and Qualification.
 Hands onexperienceinFunctional,Security,BackupandMigrationtestingof Computerized System as
per21 CFRPart 11 andAnnex11guidelines,anticipates failures & resolve issues with coordination of
Computerized System developers/ support team.
 Authoring and executing qualification/validation protocols for manufacturing, QC and
facilities/engineering
 Good Skills in proactive & effective communication with top & middle management, CSV team and
cross functional teammembers,CSV serviceproviders,Computerized System developers/Integrators
in resolving CSV and maintenance issues.
 Perform and verify Periodic review reports and propose remediation plans/CAPA to ensure the
compliance of Computerized System as per cGMP requirements.
 Acts as SME and Conduct internal Quality audits for all units, suggest/propose and continuously
monitor the implementation of remedial action plans to improve compliance as per organization
continuous improvement program to meet current regulatory requirements and industry best
practices.
 Prepares audit response to comply audit observation/improvements for regulatory authorities &
customers. Implement compliance action plans, continuously monitor & ensure all the time
compliance.
 Actively engaged in preparation of check lists, templates, formats, test cases and test scripts for
simple andbettertesting,better review of validation documents & easy understanding and assuring
compliance of computerized systems as per current regulatory requirements and industry best
practices.
 Effectivelymanagesandcontrolsthe teamremotelyforComputerizedSystemValidationsactivities of
other sites and monitors the team participation and performance during regulatory and customer
audits.
 Good knowledge in conducting Computerized Systems Vendor/Service provider Audits and provide
necessary support Vendor/Service provider to implement remedial actions to meet organization
policies.
Previous Professional Summery

3.  Technology tutor, on CORE JAVA,DATA STRUCTURE,C,NETWORKING,E-COMMERCE,C++ ,VB, Vb.Net,
HTML,XML
 Involvedanddevelopsoftware asperrequirementof ITESdepartmentof the Institute inVB,.Net,Java,
HTML, Oracle, C++ languages
 Project lead for the final year students to complete their final year projects and ITES department.
 Attachedto variousInstitutional Administrationsresponsibilities suchaspromotional policy,academic
improvement, infrastructure development etc.
 Coordinate with multiple institutes of excellence, namely; University of Burdwan, Punjab Technical
University & WBSCTE
 Manage a team of 25 members and guide 350 students
 Work as an examiner in conducting university examinations.
PROFILE
 Masters inComputerApplication(M.C.A) from Bengal College of Engineering & Technology, under
West Bengal University of Technology. Strong understanding of latest technology trends, which
include vb.net, java technology, advances networking etc.
 Proficient in professional communication and have rich knowledge the domain.
 Reliable as a fully contributing, responsible and accountable member of task/project teams with
highly honed creative, logical and analytical approach
 Multilingual with proficiency in English and Hindi
TECHNICAL SKILLS
Languages: C, C++, .Net (VB), ASP.Net, QBASIC, HTML, VB6, Core Java,
selenium,
Packages: MS Office, Pinnacle Studio , Photoshop
Operating Systems: Windows98 SE, Win-ME, Win-XPProfessional, Linux (Basic),UNIX,
Windows 7 and 10
Database: Oracle 9i,10g MS SQL server, MS Access
PROFESSIONAL EXPERIENCE
1. Mylan Laboratories Limited(Bangalore )
Presently working as Sr. Associate in IT-QA department from April 2016 to till date.
Job Responsibilities
 Support GxP IT systems validation activities at the site.
 Responsible for cite CSV SOP including creation, review and approval of the electronic data system.
 Support all audit and compliance related activities to the IT system at the site.

4.  Validation of Laboratory Software’s Standalone computerized systems (CSV) in Pharmaceutical
Companies as per 21 CFR Part 11, Annex 11, GAMP5 and other guidelines
 Involved in all the user access control and password management activates in Mylan.
2. Cyber Research Institute(November 2007– March 2016)8.5 years
Assistant Professor,ProjectLead and Head of the Department -ComputerApplicationat CyberResearch&
TrainingInstitute.(Affiliated to University of Burdwan and Punjab Technical University and West Bengal
State Council of Technical Education).
Job Responsibilities
 Developed software as per requirement of ITES department of the Institute in VB,.Net, Java, HTML,
Oracle, C++ etc languages
 Head, Department of Bachelor of Computer Application and Master of Computer Application
 Conduct lectures
 Coordinate administrative activities on behalf of the department.
 Coordinate with the University of Burdwan University and Punjab Technical University
 Was examiner of Bachelor of Computer ApplicationPart I, Part II, and Part III final examination
conducted by the University of Burdwan till 2009.
 Project lead for the final year students to complete their final year projects and ITES department.
3. ENIAC COMPUTER (August 2006 - October 2007) - 1 year
GuestLecturer -PostGraduate Diplomain Software Development. The courseswere affiliated toMysore
University&W.B.S.C.T.E. (WestBengal State Council of Technical Education)
Job Responsibilities
 Conduct lectures
 Coordinate with the WBSCTE
 Examiner of Post graduate Diploma in Software Development
PROJECTS UNDERTAKEN
Project 1 CD Library Management System
Role Developer
Language VB
Database Access
Description The activity in the software “Video CD Library Management System” is based
on adding the names of the CD’s to the software which are in the CD library.
Only the Admin has the special authority to add the record, modify it or delete
the record from the database. As the customer purchases the CD and comes to
the billing counter, the user (Admin or the end user) is supposed to enter the
name of the CD he/ she purchased. As the user enters the first letter of the
name of the CD, all the CD’s name whose particular name starts with the letter
entered will be displayed. The user can select out of those displayed. Finally a
separate will be generated for each customer. This will be saved in the
database.
Reports can be checkedof how many CD’s sold for a particular month/ year.
The admin also has the authority to provide unique username and password for

5. each user workingin that shop. VideoCD Library ManagementSystem”
software developedfora company has beendesignedto reduce the time taken
to handle the salesactivity and to increase the efficiency.Itisdesignedto
replace an existingmanual record system for reducingtime taken for
calculationsand for storing data. The system usesVisual Basic as front endand
MS Access as a backendfor the database.
The systemis strong to handle dailyoperationswhere the database is cleared
over certain time.This systemwill reduce manual work, calculationsand will
also provide periodicreports at anytime.
Project 2 Medical Shop System
Role Developer
Language VB.Net
Database SQL Server
Description Medical Shop is standalone Applicationsoftware which is developedasper
user requirements.Thisapplication developedformedical shops. This systemis
a fieldconcernedwithpurchasing and sellingmedicines,maintainingtheir
inventory,generatingsalesinvoicesand generatingremindersofexpiry date
about medicines.It requiresmore time and effortwhenall proceduresare
performedmanually.
Thus, in order to reduce time consumption and human effortthe Medical Shop
ManagementSystem applicationcan be appliedin medicalswhere manual
procedure exists. The purpose of this projectis to reduce time consumption
and human effort. Thisapplication providesuserfriendlyinterface as well.
Project 3 Homeopathy Medical Distributor Stock Management
Role Developer
Language VB
Database MS Access
Description Homeopathy Medical Distributor Stock Management is standalone Application
software which is developed as per user requirements. This application
developed for Homeopathy medical shops. This system is a field concerned
with purchasing and selling medicines, maintaining their inventory, generating
sales invoices and generating reminders of expiry date about medicines. It
requires more time and effort when all procedures are performed manually.
Thus, in order to reduce time consumption and human effort the Medical Shop
Management System application can be applied in medicals where manual
procedure exists. The purpose of this project is to reduce time consumption
and human effort. This application provides user friendly interface as well.
Project 4 Patient Information System
Role Developer
Language VB.Net
Database MS Access
Description This software is developedtostore and search patient’svisit details. In

6. “SearchPatient’sDetails” window ifyou want to search patient’svisit list
of any particular date thentype the date in the blank textbox and click on
Submit button and your list will be visible.
PIS will support registeringpatients.
Users ofthis software can search for patients by name,admissiondate,
discharge date etc
Userscan viewthe previousvisithistoriesof any patient
Systemcan maintain the list of doctors in the hospital
PIS can maintainthe listof beds/rooms available in the hospital
Patientsare categorisedinto "In Patients" and "OutPatients"
Designingthe Patient InformationSystem
The first stepis to identifythe differententitiesinthe system.The following
entitiesare identified
in our PIS :
Patient- a patientis the personwho visit the hospital for
treatment/consultation
Doctor - a doctor will be assignedto each patient.
Bed - ifpatient type is"In Patient",a bed will be assignedto the user.
Visit- a patientcan visitthe hospital any number of times.
Project 5 Website, Net Angel
Role Developer
Language ASP.Net
Database MS SQL Server
Description NetAngel,a webbased Application software which is developed using ASP.Net
and back end database is in MS SQL Server. This project “Net Angel” provides a
variety of facility to the Internet users. It aims at developing a general-purpose
Internet site that groups various functionalities. While surfing the site the
user can communicate with others via sitesmailingsystem, can create his own
mail account, can write and check mails. Users can get detailed information
from this site from Sports, current affairs, Business, Entertainment etc. They
are also able to download wallpapers from the photo gallery. The site offers a
searching feature, which enables the user to search for a specific event of any
category. He can also search for a job; can give online test, post resume for
suitable job. Net trading is also possible from this site as users can sell or by
products. The users can also participate in online trading facilities provided by
the site, they can buy or sell products through net. Products can be of different
types like electronic goods, books, watches etc. Thus users get many useful
features at one place.
In this project mainly focus on the following aspects:-
 Information Search
 Email service (Client part)
 Jobs and carrier
 Online trading
Project 6 College Canteen System
Role Developer
Language VB

7. Database MS Access
Description BIMS canteen, which is maintained through software called “College Canteen
System”. In “College Canteen System”, two types of user can handle this
software. One who can access all part of the system and another can access all
except information part. Users must give valid user name and password to
invoke in the system.
This software has mainly three parts namely:
 Information.
 Stock.
 Sold.
In information part details about customers and canteen staffs are kept.
Customers are divided into three types, they are:
 Student
 College Staffs
 Others customer
Through this software user can add, delete as well as search records of
customers and canteen staffs. All customers and canteen staffs have their
unique ids.
There are two parts of stock, first part is newentry and second isdisplay details
of stock. In first part user can add and update items in the stock, user can
maintain rates and quantities very easily. Second part displays the details
about current condition of the stock; it shows the current quantities and rates
of the presently available item.
The sold section has two parts, first deals with two tables ‘sold’ and ‘stock’ and
secondgenerate bills.Stock table is updatedthrough the transaction took place
in first part. Canteen staffs are given 10% commission for their amount of sale.
Commission is calculated through amount field of the sold table. Total
commission of a canteen staff is displayed on canteen staff form. The Bill part
displays Customer ID, Item Names, Quantities, Rate, and Total amount. User
can print receipt of the Bill and provide it to customer.
EDUCATIONAL AND PROFESSIONAL CREDENTIALS
Masters in ComputerApplication – (2007)
West Bengal Universityof Technology
B.C.A (HONS)Bachelorof ComputerApplication–(2004)
Universityof Burdwan,
DIPLOMA IN COMPUTER HARDWARE & NETWORKING – (2007)
StarlightComputer,Burdwan
FULL .NET PACKAGE (VB.NET,ASP.NET, C#) – (2006-2007)
ArdentCollaborations,Kolkata
HIGHER SECONDARY Examination (Grade XII)– (2001)
W.B.C.H.S.E(WestBengal Council of HigherSecondaryEducation)
SENIOR SECONDARY Examination (Grade X) – (1998)
W.B.B.S.E(WestBengal Boardof SecondaryEducation)

8. DECLARATION:
I herebydeclare thatthe information furnishedabove istrue tothe bestof myknowledge.
Date: _________________
Place: SABYASACHIMITRA