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    TarunSharma (5 10) (2) Interested Salary Expected 9LPA.-20JULY2021

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    CE CERTIFICATE
    Tarun Sharma is a medical device professional with over 5 years of experience in regulatory affairs, quality control, and project management. He has a Master's degree in Biotechnology and is an approved Lead Auditor for ISO 13485 and CE Marking for medical devices. Currently he works as a Regulatory Executive at Romsons Group of Industries in Agra, where he ensures compliance with ISO, CE, and other regulatory standards. He has prior experience working in quality control and auditing roles.

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    TarunSharma (5 10) (2) Interested Salary Expected 9LPA.-20JULY2021

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    CE CERTIFICATE
    59 views4 pages
    Tarun Sharma is a medical device professional with over 5 years of experience in regulatory affairs, quality control, and project management. He has a Master's degree in Biotechnology and is an approved Lead Auditor for ISO 13485 and CE Marking for medical devices. Currently he works as a Regulatory Executive at Romsons Group of Industries in Agra, where he ensures compliance with ISO, CE, and other regulatory standards. He has prior experience working in quality control and auditing roles.

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    TarunSharma[5 10] (2) Interested Salary Expected 9LPA.-20JULY2021

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    Tarun Sharma is a medical device professional with over 5 years of experience in regulatory affairs, quality control, and project management. He has a Master's degree in Biotechnology and is an approved Lead Auditor for ISO 13485 and CE Marking for medical devices. Currently he works as a Regulatory Executive at Romsons Group of Industries in Agra, where he ensures compliance with ISO, CE, and other regulatory standards. He has prior experience working in quality control and auditing roles.

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    Download as doc, pdf, or txt
    59 views4 pages

    TarunSharma (5 10) (2) Interested Salary Expected 9LPA.-20JULY2021

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    CE CERTIFICATE
    Tarun Sharma is a medical device professional with over 5 years of experience in regulatory affairs, quality control, and project management. He has a Master's degree in Biotechnology and is an approved Lead Auditor for ISO 13485 and CE Marking for medical devices. Currently he works as a Regulatory Executive at Romsons Group of Industries in Agra, where he ensures compliance with ISO, CE, and other regulatory standards. He has prior experience working in quality control and auditing roles.

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    Tarun Sharma

    4/93 Avas Vikas Colony, Hathras


    Uttar Pradesh
    Tel: 9997318668
    E-mail:[email protected]
    Date of Birth: 22/04/1990

    Medical device professional with strong background in single use disposables, reusable medical
    devices(Class I, Class II and Class III) . Broad technical competencies, spanning Regulatory
    Affairs, Quality, Manufacturing, Project Management, QMS & Product Certifications. Approved
    Lead Auditor for ISO 13485 & CE Marking (Medical Devices).

    Experience..
    Romsons Group of Industries (Agra, Uttar Pradesh).
    Duration: From 09 Jan 2017 to till now.
    Designation: Regulatory Executive.
    Nature of work: ISO/CE-MDD/ SLA / CLA (CDSCO) Compliance, Clinical Evaluation as per
    Meddev2.7/1 Revision 4, Usability Engineering.
    TotipotentSC Scientific Product Pvt. Ltd..(Gurgaon, Haryana).
    (A Subsidiary of Cesca Therapeutics Inc., USA).
    Duration: From March 2013 to Jan 2017.
    Designation: Quality Control Executive/Management representative.
    Nature of work: ISO Compliance and Documentation & Auditing.
    Rapture Biotech Agra (Uttar Pradesh).
    Duration: Aug.2012 – Jan2013.
    Designation: RA (Research Associate), in Pharma Micro and Chemistry Lab.
    Nature of work: Research work and Training.

    Rasna India Pvt. Ltd., Selakui (Uttrakhand).


    Duration: January 2012 to July 2012.
    Designation: Quality Control Executive.
    Nature of work: Testing and Documentation.

    Education
    Post-Graduation: M Sc. Biotechnology from Doon PG College, HNB Gharwal University (UK) .
    Graduation : B Sc. Biotechnology from Dr. MPS College, Dr. B.R.Ambedkar University (U.P) .

    Schooling : Intermediate (XII) from U.P. Board (U.P).


    : High school (X) from U.P. Board (U.P).

    Professional Training
    Done ISO 13485 Lead Auditor training from BSI India.
    Duration- 5 Days.
    Location- Delhi.
    Done ISO 13485 Internal Auditor training from DNV India.
    Duration- 3 Days.
    Location- Gurgaon.
    1

    Basic Bioinformatics and Plant Tissue Culture Meristem Culture of Banana.


    Page

    Duration: 1 month.
    Location: Harihar Biotech Agra (hhbio).
    Preparations and various type of microbiological test of Biofertilizers.
    Duration: 4 month.
    Location: Bhagirathi Research and Training Center (Dehradun).
    In vitro regeneration of lychee(litchi chiensis sonn) .
    Duration: 4 month.
    Location: Forest Research Institute, Dehradun.

    Various Pathological and clinical examination of Human Blood.


    Duration: 4 month.
    Location: Kamayani-Essorts Heart and Neuro Truma center.

    Online Course-
    a. Short Course: Through History with Standards
    b. An Introduction to Standards: Why, Where, and How Are They Developed?
    c. U.S. Delegates to International Activities: Roles and Responsibilities
    From www.StandardsLearn.org (American National Standards Institute)
    d. Six Sigma White Belt from Aveta Business Institute
    e. Managing Health and Safety in Healthcare Biological Agent Hazards from www.alison.com

    Knowledgebase (Skills)
    Computational Skills:

     SAP / ERP (QC,Prodution Module)


     Programming & Scripting Languages:, C,C++.
     Platforms & Packages: Windows (XP, Vista 7 & 8).

    Documentation Skills
     Compliance, Review and awareness of ISO 13485:2012&2016 and ISO 9001:2008&2015.
     Having Exposure to Regulatory activities (Registration/Re-registration of medical devices in
    DCGI, CE Marking, preparation/compilation data for the dossier).
    • Clinical Evaluation Report preparation and review as per MEDDEV 2.7.1 Rev 4
     Risk Management Report preparation and review as per EN ISO 14971:2012
     PMS Report preparation and review as per MEDDEV 2.12.1 
     IFU, Label preparation and review as per EN ISO 15223‐1:2016 and EN 1041:2008+A1:2013
     Review & approval of product labeling & Promotional Material. 
     Usability Engineering, Creation of Usability Eng. File as per 62366.
     Coordination with concerned departments like Quality Control, Quality Assurance Manufacturing
    and Research Development to review technical documents for the inclusion in Medical Device
    File as CE MDD And Medical Device Rule 2017
     Planned and executed Internal Quality Audits for all the function in the organisation, prepared
    audit report, take timely corrective actions and monitor its implementation on plant level and
    ensured audit closure on time
     Preparation of SOP’s, Templates, Specifications, STP’s, and Reports.
     Preparation of Quality Plan.
     Preparation of Specification in SAP, Incoming QC and QC Completion.
     Drafting & Implementation of Standard Operating Procedures (SOP’s) & Process validation
    Protocol.
    2
    Page
    Lab proficiency:
     Microbiological techniques
     Quality control techniques (microbiological) in pharmaceutical company etc.
     Environment monitoring
     Microbial limit test (MLT).
     Culturing (PTC & ATC).
     Micro propagation of Plants- Litchi, Banana etc.
     Instrument Handling Known –Biosafety Cabinet, Laminar Air Flow, Double Door Moist
    heat sterilizer, Dry heat sterilizer, leak test apparatus, BOD incubators (22.5-+2.5&32.5+-2.5),
    Peristaltic Pump, HPLC, Centrifuge, Spectrophotometer, Compound microscope, colony
    counter, Hygrometer, Particle counter, etc

    Research Experience
    Master's Dissertation
    External Project:
     Title: “Various Microbiological and Chemical Test in Pharmaceutical lab.
     Duration: 4 Months.
     Location: Kalindi Medicure Pvt. Ltd. Selakui, Dehradun, Uttrakhand.

    Bachelor’s Dissertation
     Title: “Microbial interactions during upper respiratory tract infections (Isolation
    of microorganism from upper respiratory tract infection.”
     Duration: 4 Months.
     Location: Dr. Mps Memorial College Of Business Studies .

    Workshops and Conference:


     Presented and demonstrated Poster Presentation on Green House Effect and Global
    Warming At Biotech Fest Agra.
     Took Part in Science Exhibitions’ Second Position in Zonal Level and First Positions at
    City Level.

     Personal Information

    NAME TarunSharma
    FATHER’S NAME Dinesh Kumar Sharma
    DATE OF BIRTH 22-04-1990
    GENDER Male
    LANGUAGE Hindi, English
    NATIONALITY Indian
    MERITAL STATUS Married
    PERMANENT ADDRESS 4/93 Avas Vikas Colony Hathras Uttar Pradesh

     Declaration
    I hereby declare that information furnished above is true to the best of my knowledge.

    DATE:
    PLACE: (Tarun Sharma)
    3
    Page

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