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    Viney Kumar Not Interested 28march2022

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    Viney Kumar Not Interested 28march2022

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    Viney Kumar Not Interested 28March2022

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    Viney Kumar Not Interested 28march2022

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    of 4

    TECHNICAL QUALITY PROFESSIONAL

    QA /Quality Assurance Dy.Manager


    VINEY KUMAR

    Msc. in Pharmaceutical chemistry

    Address: Vill.Tikkri, P.O.Taksal, opposite

    LIG-B-24 sector, 4 Parwanoo

    Tehsil Kasauli, Distt. Solan (H.P.)

    Cell No. 07018945069 & 09805343769

    E-Mail -: [email protected]

    Career Objective: -

    To continually develop my technical skill in the field pharmaceutical and Biotechnology (In vitro IVD/Medical
    devices /Biochemistry reagents) manufacturing in India. Establishment of manufacturing units/product launch/
    product design/production strategies and control. To use my knowledge and skills in best possible way for the
    betterment of environment that can encourage my learning and creativity, provides an exposure to new ideas and
    stimulate personal and professional growth”.
    Summary: -

    QA Dy. Manager with 10.7 years’ experience in Quality Control division , Quality Assurance & Technical
    filing documentation for WHO,CE marking & ISO Approved Analytical Chemist for Pharmaceutical and QC -
    Medical devices diagnostic Kits

    CORE COMPETENCIES

     Quality control & Quality  QMS head, MRM ,Internal Audits, India head high Technique
    assurancel Quality system head of Q pulse.

     Handling QA department by individual responsibility, can


    handle 20-50 person team.

     QA and QC documentation, Handling of documents like-


    OOS,OOT,BMR,LIR,Market
    complaint ,CAPA ,SOP,STP,Specification, Protocol &
    calibration /Validation

     Main point of control to Audit and Quality operations.

     Centralised documentation

     Overall Product acquaintance of below products (Including Testing


    ,trouble shoot and regulatory documents) :

     pharmaceutical(Tablets, capsules and syrup)

     Rapid Kits- HIV (Biline,Triline and tridot),HbsAg ,HCV(Tridot


    and Biline) , Dengue(IgG,Ns1and combo),Malaria(Pf/PV , PAN
    and Pv)—ALL Rapid range.

     Bioassay -Biochemistry reagent analysis (CRP, ASO latex,


    bilbuirine, Widal, Uric acid, Urea, Glucose etc.
     Instrumention and
    machine expertise  Instruments -UV spectroscopy, IR spectroscopy,
    HPLC(Shimadzu,Dionex and Agilient), Autotitraror, Polarimeter, pH
    meter, Conductivity meter, Leak test apparatus,Haemotaliser ,fully
    automatic semi automatic analyser, Centrifuge etc.

     Method Validation, Method Verification, Method transfer,


    Protocol preparations, LNB issuance, complete Data integrity of
     Method Validation and AMV.
    Audit trial
     Empower Audit trial, System audit trial.

    • Machines -Antigen coating machine(Zeta,Biodot), Device roller


    pressing, Guilottine Cutter,Fully device assembly machine ,Dispenser (Zeta
     Audits/Self-Inspection and Kimbio) , Indicator machine -taping, core taping and LC detection.

    • Internal Audits, External Audits- ISO 13485, ISO 9001 ,WHO round 8
    Malaria,NABL:2017, ANVISA, PICS, MHRA, many country specific like
     Vender Qualification & Zimbawe, TGA and Ukraine etc.
    Supplier Management

    • Vender Audit, Vigilance, Post market survellience and Vender


    approval. Post market survellience and CRM program.
     Training

    • Training program internal and external, Training calender and


    Competency Matrix and competency training.

    Dossiers Preparation for


    WHO & Filling.
    • WHO dossier preparation, CDSCO technical file preparation and
    Marketing Technical sheets.

    Experience:-
     Total Experience : About 10.7 years
     2.5 Years of experience as an executive in TORRENT PHARMACEUTICALS LIMITED from
    06 .08. 2008 to 18.01.2011
     1.2 Years’ experience as an executive in ALEMBIC PHARMACEUTICALS LIMITED from
    15.03.2011 to 15.05.2012
     3.5 year experience in J mitra biotech ind. at diagnostic biotech Ent. Unit Parwanoo as QC in-charge
    from 16.05.2012 to 24.10.2015.
     2.1 years in NECTAR PHARMACEUTICAL LTD. As a Sr. executive in QC Derabassi from
    26.05.2015 to 10.10.2017.
     1 year experience in Quality department as a QA Head in Omega DX Asia Pvt ltd.
     Currently working from last 4 months in Pharmafillates R&D ,USFDA approved and NABL approved facility
    as a QA Dy.Manager.

    ACADEMIC CREDENTIAL:

    Course University /board Year (% /Grade)

    Msc.in Pharmaceutical Punjabi University Patiala 2008 62.8 %


    chemistry

    Bsc.in K.U.K University 2005 60.0 %


    Non medical

    (10+2)th Non medical HP board 2002 66.6 %

    10th (Matric) HP Board 2000 62.8%

    2 year computer Hartron Institute K.U.K 2005 and 2006 A grade


    course University

    INDUSTRIAL TRAINING:-
    Did Industrial Training from IND-SWIFT LTD. Parwanoo for one month Chemical Testing with calibration
    of Various Instruments.
    FEW LINES ABOUT MYSELF:
    •I am confident, punctual and positive attitude person.
    •I have carry no ego in life
    • I am experienced in Invitro diagnostic departments -QA, Regulatory and QC.
    • I also handle the Production department with 80-100 manpower.
    • I have successfully face the Audits -WHO pre-qualification round 8 of Malaria pf/pv,Malaria pf and
    Malaria pf/pan. , CDSCO, MHRA, FDA AND MANY COUNTRY specific.
    • I know how to Reply regulatory queries of regulatory agencies like -WHO, FDA ,MHRA,PICS and CDSCO.
    • My mantra is "When we go tough, tough gets going ".
    STRENGTH:-
    Self-Confidence, doing a job with confidence and support organization as a team work.
    Good communication skills also, better teller and listener, Responsible & peaceful person.
    Hardworking, very much determine towards every given task and carrying a leadership quality, very graceful
    behavior, Honest, Punctual with positive Attitude.
    HOBBIES:-
     Internet Surfing, Listening ghazals & Playing Cricket
    Audits Faced:-

     COPP WHO – GMP (Critical and non critical Diagnostic products)


    License and Evaluation of critical (HIV, HCV & HBsAg Rapid and ELISA) kits.
    ISO 13485 AND ISO 9001:2008 CERTIFICATE from TUV South Asia.
     WHO Geneva, ANVISA, CE marking BSI ,Zimbabwe & Ukraine
     ISO :13485
     CE marking
     NABL 17025:2015 and NABL 17034:2016
     USFDA
     Companies Audit faced also : Glenmark, Sentiss, Galpha etc.

    PERSONAL INFORMATION:-
     Candidate Name : Mr. Viney Kumar
     Father’s Name : Mr. Prem Singh
     Date of Birth : 24 October, 1984
     Marital Status : Married
     Children : 1
     Nationality : Indian
     Presently Residence at: Vill. Tikkri, P.O.Taksal, opposite LIG-B-24 sector,4 Parwanoo Tehsil Kasauli, Distt.
    Solan (H.P.)
    Permanent Address:
    • Vill. Tikkri, P.O.Taksal, opposite LIG-B-24 sector,4 Parwanoo Tehsil Kasauli, Distt. Solan (H.P.)
    CURRENT SALARY :6.5 LAC PER ANNUM.
    Expected: Negotiable
    Declaration: -
    I hereby declare that all information given up is true & best of my knowledge & Belief I shall try to satisfy all with
    hard work, sincerity and devotion to duty.
    Place: –Parwanoo (HP) Viney kumar
    Date -01.03.2019

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