SREE GANESH R, FDA Validation Engineer
No. 63, 2nd cross,
Jai Jawan Nagar,
Subbanapalya Main Road,
Bengaluru – 560043.
Highly experienced, dynamic, and effective professional with 5 years of experience in the field of Validation, Quality control etc.
Recognized for the ability to work collaboratively with cross-functional teams and the clients. Served as a strong team member who promoted the exchange of ideas in an open forum to facilitate an organization of high performers. Professional strengths include:
Calibration of equipment’s/instruments.
Safety Document Development
Achievement oriented with excellent people management skills and an ability to manage change with ease.
Professional strengths include Qualification and calibration of equipment/instrument and safety documents development.
Good knowledge of FDA 21 CFR PART 11,EU Annexure-11,GAMP-5 guidelines and GxP (GMP,GDP,GCP and GLP)standards.
Good knowledge of end to end validation documents – VP, URS, FRS, CS, FRA, TM, IQ, OQ, PQ and VSR.
Good exposure to handle regulatory audits like WHO, USFDA, Anvisa, EMA, Turkey, DCGI and customer audits.
Excellent interpersonal, communication and organizational skills with proven abilities in team building & management.
Continuous process improvement to drive strong and sustainable productivity gains and quality improvements.
Analytical, innovative, dedicated, well-motivated, faithful, quick thinking and tenacious with exceptional problem solving and strategizing skills to achieve the end objective.
Successfully able to develop self and others and hold people accountable along with empowering they demonstrate team commitment and team leadership.
Experience & Achievements
Presently working in Wipro Technologies as Senior FDA consultant, Bangalore, India
Jan 2017 to till date
Review of Validation documents.
Planning and scheduling of validation activities.
Other responsibilities as and when assigned by the management.
Review of Test data and test scenarios specific to the product workflows
Good work coordination with members of other units.
Senior Executive-CSV, IMEDGlobal Solutions India pvt ltd, Bangalore, India
Apr 2016 to Jan 2017
●Review and understand URS and FS documents.
●Create Test data and test scenarios specific to the product workflows.
●Provided Qualification Support-Execution of IQ,OQ,PQ/UAT scripts.
●Responsible for preparation of end – to – end validation deliverables.
●Good work coordination with members of other units.
Senior GLP and Validation Executive, Norwich Clinical Services Pvt Ltd. Bangalore, India Feb 2011 to Apr 2016.
●Performing validation activity with the assistance of respective user unit.
●Carrying out calibration of equipment’s /instruments.
●Planning and scheduling of validation activities.
●Issuing System Identification numbers for all equipment’s/instruments.
●Maintaining, preparing and updating Validation Protocol Master List.
●Preparation, review, and training new recruits on SOPs, work instructions.
●Work allocation and coordination with members of other units.
●Handling queries for management/ Regulatory authorities/ sponsors.
●Archiving the required document as required.
●Preparation of standard Operation procedures related to Validation activities.
●Preparation of validation plan, Validation protocol/ Validation summary report with regard to equipment’s/ instruments/ computer software.
●Other responsibilities as and when assigned by the management.
Worked as Quality Control Trainee Chemist in Southfield Paint Private Limited Bangalore, India for about 8 months. July 2010 to Feb 2011.
●Prepare and test samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the standards or requirements of the project.
●Prepare documents that report the results of the lab work.
●Also be responsible for minor equipment troubleshooting and repair.
●Ensuring timely, quality aggregate reports.
●Test finished products, raw materials.
B.E. in Chemical Engineering from MVJ College of Engineering Bangalore, (affiliated to Visvesvaraya Technological University, Belgaum in July 2010)
P.U.C from National Junior PU College (Department of Pre-University Education, Bangalore in the year 2004-06)
S.S.L.C. from Karnataka Secondary Education Examination Board, Bangalore in the year 2003-04.
Polymer Composites In Insulation System carried out at Central Power Research Institute, Bangalore.
In this project we try to reduce the void space in insulation system by cenosphere and nano composite material alumina which is blended with polymerized compound, polymethyl methacrylate and polystyrene.
The outcome of the filling materials is that the moisture and dust particles which accumulate in the void can be avoided further by avoiding partical discharge and treeing effect, else which results loss in insulation system and also reduces the life span of the material.
Date of Birth 10 February 1988
Languages Known English, Tamil, and Hindi
Marital Status Married
Permanent Address No. 63, 3rd cross, Jai Jawan Nagar, Subbanapalya Main Road, Bengaluru – 560043.
Reference would be provided upon response/request.
I hereby declare that all information provided here is true and authentic to the best of my knowledge.
Sree Ganesh R