Engineer Sales

VISHWESH R.SALUNKE

E***, Ashish JK Apartments,

Thubarahalli Extended road,

Thubarahalli,

Whitefield Road

Bangalore -560066

Mobile : 888-***-****

Landline : 61716815 Email : ********@**********.*** Objective :

Promising experience in Computerized System Validation, Quality Management system related to IT and implementation of regulatory requirements in Life Sciences/Pharma Industry. Seeking for a better opportunity to enhance and prove my ability in the organization to develop myself and for the organizational growth by providing my complete efforts with Determination, Dedication and Smart Work.

Highlights:

Overall experience of 8 years with Life Sciences/Pharma Industry in the Validation and Computerized System Validation.

Experience and acquainted of Computer System Validation and Equipment Validation.

Familiar with the process validation, Cleaning validation in Stability studies/Formulation plant.

Familiar with Organizational Techniques like QC tools, SAP, HP ALM,.

Familiar with SDLC Methodology,V-Model,Waterfall model,Agile, Data Management, US FDA 21 CFR Part 11 Electronic Records and Electronics Signatures.

Strong analytical skills,leadership skills and problem solving skills General Skills:

Languages: C language

Operating Systems: MS Windows/XP/7/8/10.

Office Tools: MS Office/Office 365, Outlook and MS Access Organizational Experience:

Deputy Manager Bangalore India.

Syngene International Limited. Feb 2016 to Dec 2019

Qualification and re-qualification expertise related to Equipment, Instrument.

Experience in Computer system validation in line with 21 CFR part 820/Part 11 compliance, GAMP 5, ICH Q9 followed by ISO 13485 and EU Annex 11, related to all computerized systems.

Expertise in CSV validation of specialized Chromatography instruments from Agilent, Waters, Shimadzu, Thermo and other lab instruments

Responsible for preparation of complete CSV deliverables and Testing for the GxP Computerized Systems/Data Control Software’s Thermo Chromlean 7.5, Water’s Empower used with the Water’s, Agilent Chromatography Instruments.

Involved in the End to End support to the Team in managing systems from initial assessment to reporting and releasing of the Computerized systems.Good Documentation Practices

Authoring and peer review of key validation documents as per GDP Practices.

Preparation of the CSV SOPs related to managing, usage, testing and reporting.

Leading a team of 8 Members and training the team on the subject of the validation, Computerized system validation, Data Management and Quality Management.

Responsible for Planning, Assigning and reviewing the tasks performed by the subordinates, in the team and supporting the team members for completing the projects.

Overview of projects handled: Applications like Chromelean, Empower, Tiamo,Winlab-2

Responsible for managing the system users, data management and review of Vendor documents including equipment validation and CSV

Support during client Audits and internal Audits.

Review and evaluation of Change controls, Deviations and CAPA related to equipment, systems followed by good experience in training the CFT’S.

Performing periodic audit trail reviews and user management reviews for computerized and Non -computerized systems. Senior Engineer Oman

Business International Group. Oct 2011 to Nov 2015

Installation, demonstration, validation of Perkin Elmer Analytical instruments (with accessories) such as UV/VIS, FTIR, AAS, POLARIMETER, GC and laboratory equipment’s from Buchi, Thermo, Sartorius in clients location Oman pharmaceuticals, National Pharmaceuticals

Installation/Computer System Validation of equipment’s as per the Standard Operating Procedure.

Program / script designing to optimize the Application software corresponding to the customer application.

Software Validation.

Technical Training / Demonstration to the customer.

Maintenance by way of Calibration and troubleshooting of instruments.

Installation Qualification, Performance Qualification & Operational Qualification.

Online Technical Support.

Senior Field Service Engineer. Oman

Imtac llc Mar 2011 to Sep 2015.

Installation, demonstration, Field servicing of Agilent HPLC, GC-MS, Eltra CSanalyser, JPSelectaIncubators/strelisers/Centifuges/Ovens/Spectrophotometers, Biological Microscopes from Nikon, Medical instruments from Philips Medical Systems

Contributed in service revenue growth, sales promotion of consumables/spares and also AMC.

Represented the company in ARABLAB Dubai, GESS Exhibition and helped in enquiry /order generation/sales leads. Service Executive Bangalore

Agilent Technologies Sep 2003 to Sep 2004

Installation, demonstration and servicing of HPLC, Gas Chromatograph.

Contribution in Service revenue growth .AMC and spares, consumables sales promotion.

Some of our Customers were Biocon, Strides Arcolab, ITC, Rallis, IISC etc. Service Executive Bangalore

Niulab Equipment Co. Private Ltd, March 2000 to Jan 2003

Installation, demonstration, preventive maintenance. and Field servicing of GBC Atomic Absorption Spectrophotometer, UV- VIS Spectrophotometer .Mettler Toledo Moisture Analyser, pH/Ion Analyser, Precision weighing Balance’s .

Contributed in Service revenue growth, sales of AMC’S,spares consumables .

Some of our prestigious customers were ITC Ltd, GE, Rallis, Nestle (I) Ltd, Max Pharma Ltd, Glaxo SmithKline Bangalore to name a few.

Represented the Company in Bombay Exhibition Centre for exhibiting company products and generated enquiries . Sales and Service Engineer. Mumbai

Elico Ltd April 1998 to Jan 2000

Installation, demonstration and servicing of Analytical Instruments like Water Quality analyser, Flame photometer, UVVIS Spectrophotometer, Spectro Fluro meter, Atomic Absorption Spectrophotometer.

The work involved the component level servicing and troubleshooting of all these instruments both at the customers place as well as in-house.

Attending the Annual maintenance contracts of the customers. Sales enquiry generation, quotation submission and follow- up, Order processing, involvement of delivery process and Installation process.

Some of our prestigious customers were Glaxo India Ltd, Johnson and

Johnson Ltd Mumbai, Institute of cotton research Nagpur, Western Regional Instrumentation centre Mumbai to name a few.

Represented the company exhibition at Bombay Exhibition Centre, Pune University. Academic Details:

Bachelor of Engineering (Electrical & Electronics) from SDM College of Engineering and Technology, Dharwad

(Affiliated to Karnataka University) with 62%.

Personal Details:

Date of Birth: 16 July 1974.

Languages known: English, kannada, Hindi, Marathi, Konkani.

Hobbies: Music, Sports, Reading.

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