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Computer system validation, Regulatory compliance

Pune, MH, India
March 14, 2018

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Mobile: +91-741*******, E-mail:

To attain a successful position in a dynamic organization by applying the creative and technical skills which I have and achieve excellence in my related field and enhance my future career growth. I am very good working in a Team environment, and taking up individual responsibilities.

Employer : Emcure Pharmaceutical Limited

Designation : Assistant Manager (IT-QA)

Duration : 9th Jan 2017 to till date.

PLC Based system validation, Equipment validation, Computer system Validation,

Validation Documents preparation for the QC Laboratory system, Enterprises system as per VMPCS (URS, GxP Assessment, FDS, DDS, CS, VPP, IQ, OQ,PQ, Risk Assessment, RTM, VSR)

Execution of the IQ, OQ, PQ protocols for QC Laboratory Systems and enterprises system.

Risk Assessment, Change Control as and when required

Review of FAT document from vendor.

Preparation of SAT document.

Preparation of Validation Document for PLC based system and execution.

Supporting the QC, QA in validation activity.

Employer : IVYWorks Advisors LLP

Designation : Senior Validation Engineer

Duration : 1st September 2013 to till date.

IVY Works provides consulting, development and support services related to compliance, validation, IT, computer systems, and software applications to clients in the life sciences industries.

Good Documentation Practices

Computerized System Validation

Qualification / Validation of Utilities and Equipment

Regulations and Industry Standards (GAMP 5; US FDA, 21 CFR Part 11, 210, 211, 820; EU Annexure 11; ICH 7 & 9).

Testing and Execution of OQ protocols for Track and Trace application projects. Involved in the pre and post migration activity (GO Live) for OAMS, RA Manager, Track and Trace, Plant Maintenance and Material Tracking Project. Equipment validation of Pick and place automation for secondary line packing area.

Testing and Execution of OQ protocols for Online Artwork Management System (OAMS) application Project.

Validation of “Material Tracking and Plant Maintenance Application”. Involved in developing the missing documents like OQ & PQ for the different modules. Prepare, Testing and Execution of IQ, OQ and PQ protocol’s for Plant Maintenance and Material Tracking projects.

Execution of PQ protocols for different modules of LIMS application. Developing the DMD (Data Migration Document) for Chromeleon application. Execution of PQ protocols for DMS (Dossier Management System) application. Trained users on protocol execution and GDP.

Validation and developing the documents (FS, DS, IQ and OQ) for Pick and Place Automation for Countec 2 Secondary packing area.

Prepared user manual (Operation and Maintenance Guide) for Stability Chamber

Projects Handled:

Consultant at Dr. Reddys Laboratories Hyderabad

Developing the documents, testing, Execution, planning, review of below mentioned projects:

Data Acquisition System(DAS), Laboratory Management System(LMS), HVAC Filter Management System(HFMS), Environment Management System(EMS), L2 Integration, Global Serialization Track & Trace(GST&T), Process Analytical Technology (PAT), Empower 3 Chromatographic Data System (ECDS)

Preparing the Documents like VP,

Protocol like IQ, OQ, PQ, specifications

Online Artwork Management System(OAMS), Material Tracking(MT), Track and Trace, Global Serialization Track & Trace (GST&T), LIMS ETC.,

Consultant at Sun Pharma Limited, Unimed Technology Limited

Involved in CSV support for Lab Instrument applications like: Pharmspec, Rheocalc T, Klima, TOC Control system, ICDAS for Stability Chambers, Lab Solutions

Employer : Global Eco carb Pvt Ltd

Designation : (Production/Quality) Engineer

Duration : November 2011 to August 2013.

Handling of IISC project (Charcoal Gasifier) also called Reactor in GEPL.

Technical support & monitoring of the operating units.

Scrutinizing plant operating costs, losses & potential optimizations.

Identifying, developing proposals & feasibilities for capacity enhancement & energy conservation.

Pre-commissioning & commissioning of the new projects.

Material and energy balance of plant, steam and water balance to identify losses. Calculation of specific Energy Consumption of plant.

Environmental compliance, monitoring & reporting.

Production loss reports writing and trouble shooting.

Maintaining the Activated carbons grades.

Maintaining the kiln temp, steam, feed rate, input and discharge.

Operating the kiln, pre activation, post activation and Reactor.

Maintaining the temp, pressure, feeding and discharge of Reactor.

Maintaining the gas quality and controlling the chemical reactions.

Assisting with providing key input in technology selection regarding

Conversion of coal to synthesis gas.

Updating and finalizing the process design basis.

Assisting with the evaluation and conclusion of specific selected technology partners by working with authorities and organizations within the coal gasification business arena.

Analyzing and assisting with the optimization of the value chain design for Syngas Conversion unit for the lowest operating cost with selected technology.

Involving with Licensor discussions and plant visits.

Providing input into plant commissioning, operating and maintenance.

Employer : Indu Plant services. JSW Steels Ltd. Torangallu (Bellary)

Designation : Process Engineer

Duration : December 2009 to November 2011

Total in-charge of Beneficiation process i.e Coke oven battery, Water pump house, Gas condensate pump house, Primary gas cooler, Electrode Tar Precipitator, Exhauster, Desulphurization, Ammonia scrubbing, Decanter, Furnace and Gas holder

Capable of handling both chemical and Mechanical issues.

Operation and Maintenance of above machines including production.

Maintaining the temp and pressure of entire process.

Capable of handling both Mechanical and Electrical.

Monitoring and controlling the parameters.

Handling the Distillation column, maintaining the temp and pressure according to the situation.

Management and Technical Courses Attended

Basic Management & Human Relations

Process Hazards Analysis

Project Management by PIM

Goal Setting & Work Planning

Effective Presentation Skills

Time and Stress Management

Time Management

Team Building

Goal Setting and Goal Getting

Effective Letters, Reports and Presentations by PIM

“SIMULATION OF DISTILLATION COLUMN”. Distillation columns are complex gas-liquid two-phase systems and one of the most frequently used unit operations in the chemical/petrochemical/distillery industry. Many correlation and rules-of-thumb have been established to fluid the design of distillation columns. However industrial columns often still fail to reach their design fails because of limited knowledge about momentum transfer, heat transfer and mass transfer in different systems. Column simulators are useful tool to fill this need. In this work we explore possibility of developing column simulators using HYSYS. The efficiency of the simulation results are compared with experimental packed bed distillation column. Also, the result of simulation is compared with that of mathematical model.


Name of Institution


Class Obtained

B.E (Chem.)

B.I.E.T college, Davangere.


First class


Kittle science college Dharwad.

Karnataka Pre-University.

First class

S. S. L. C

K.P.E.S school Dharwad.


Secondary Education Examination Board.

Second Class

Operating Systems: Windows 95/98/2000/Xp/Vista.

C Programming.

MS Word and MS Excel.

Hardware & Networking.

Powerpoint Presentation

Good Communication Skills

Team player and individual achiever

Honest, Hardworking, Self-motivated, Goal oriented

Very enthusiastic to learn new things

Capable of working around clock

Name : Raghavendra.G.Kammar

Father’s Name : Gurunath kammar.

DOB : 11/03/1984

Gender : Male.

Marital Status : Single.

Native : Dharwad

Languages Known : English, Hindi, Kannada and Telugu.

Passport Number : K3819004

I here by declare that the above given information are true to the best of my knowledge and belief.


Date: (raghavendra)

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