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    Anoop Gokhale Resume- Oct 2024

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    baluchakp

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    Anoop Gokhale Resume- Oct 2024

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    baluchakp
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    5 views3 pages

    Anoop Gokhale Resume- Oct 2024

    Uploaded by

    baluchakp

    Copyright:

    © All Rights Reserved
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    CURRICULUM VITAE

    Anoop Gokhale
    Permanent Address:
    Villa 533, Omaxe City 2
    By-Pass, Indore (M. P)
    +919977606247/ +91 8319745939 E-mail:
    gokhaleanoop@gmail.com
    Passport : P6826135

     PROFILE:
    • Experienced qualified professional with more than 21 years of hand on experience in
    Quality Assurance & Manufacturing Dept in API Industry.
    • Experience of Regulatory and customer inspections, which includes 5 USFDA, # TGA, 2
    EDQM, 2 MHRA & 1 WHO inspection.

     EDUCATIONAL QUALIFICATION:
    • M.Sc. (Applied Chemistry-Regular) from S.G.S.I.T.S Indore [ [M.P.]in 2003.
    • B.Sc. [Fishery Science-Regular] from Holkar College Indore [M.P.] in 1999.

     PROFESSIONAL EXPERIENCE: 21 YEARS


    Last Organization: Rini Life Sciences Pvt Ltd, Indore, M.P.
    Designation: Head -Quality (Senior Manager -QA) from May-2024 to Oct 2024
    Current function: Looking after Site Quality Operations.

     JOB PROFILE: -
    ▪ Handling of Internal Audit, Customer Audit and Regulatory Audit & its compliance.
    ▪ Qualification of Vendor, Service provider and Contract lab.
    ▪ Handled the Process, Cleaning validation and Qualification of equipment, Area and Utility.
    ▪ Handling of Training and development of all Department.
    ▪ Preparation training modules, preparation of GMP, Technical Module, Quality system module.
    ▪ Classroom training of Employees training as per SOP, GMP and Technical training.
    ▪ Handling of Change Control, Deviation, Investigation and CAPA Management and effectiveness.
    ▪ Quality management review.
    ▪ Review of documents like MPCR, BPCR, ECR, Qualification and routine QMS documents.
    ▪ Review the SOP of all Dept at Site.
    ▪ Review of APQR
    ▪ Preparation of new SOP, handling of QMS related document.
    ▪ Routine SOP review, plant inspection and audit work as per cGMP norms.
    ▪ Details process of Qualification/Requalification of equipment protocol review (Like:
    URS/DQ/IQ/OQ/PQ and periodic qualification protocol of equipment’s. Temperature mapping
    protocols, Layouts/drawing review, area qualification,
    ▪ Handling of internal audit as a lead Auditor
    ▪ Handling of ISO, safety audit and its document.
    ▪ ISO related documents like QMS and HSE objective preparation& periodic review.
    ▪ Preparation and review of Safety aspect, impact and HIRA.
    ▪ Plant observation w.r.t cGMP and document related & its compliance.
    ▪ Audit compliance and CAPA compliance.
    ▪ Co-ordination with other department like QC, Engg., Warehouse, Manufacturing & HR to comply
    the Quality system.
    ▪ Knowledge of plant equipment and connected system.

     PROFESSIONAL DEVELOPMENT /TRAININGS:


    ▪ Training on ICH-Q7 Guideline for API.
    ▪ Train the Trainer.
    ▪ Training on SOPs, cGMP, GDP and Data Integrity (By Ex. USFDA auditor).
    ▪ SAP Training, 5S Awareness Training.
    ▪ Qualification and Validation training.
    ▪ Qualified & Certified GMP Auditor.
    ▪ Vendor Auditor & Internal Auditor.
     EMPLOYMENT HISTORY: -
    S.No. Organization Designation Duration
    1. Ranbaxy Labs Ltd. Dewas (M.P) Trainee-Production Oct-2003 – Apr-2004

    2. Ranbaxy Labs Ltd. Dewas (M.P) Executive-Production Apr-2004-Nov-2014

    3. Sun Pharmaceuticals Executive -QA Nov 2014 -Nov-2016


    (Ranbaxy Labs Ltd., Dewas)
    4. Zydus Life Sciences, Vadodara,(Guj.) Deputy Manager -QA Dec 2016 -Jan 2021

    5. Symbiotec Pharma Lab, Indore, (M.P) Manager -CQA Jan2021- May-2023


    6. Enaltec Labs Pvt. Ltd, Indore, (M.P) Manager -QA (looking Dec-2023 -May-2024.
    Site QA Operations)

    7 Rini Life Science Pvt.Ltd ,Indore(M.P) Sr.Manager-QA(Looking May-2024 – Oct 2024


    Site QA Operations)

     PERSONAL PROFILE: -
    Fathers Name : Late Avinash. Gokhale
    Date of Birth : 25th July 1978
    Nationality : Indian
    Language Known : Hindi, English and Marathi
    Marital status : Married

     PROFESSIONAL REFERENCES: -
    Mr. Nitin Tiwari Mr. Mehul Patel
    Vice President -QA AVP Corporate Quality
    Mo. +91 7879673222 Mo. +91 8511156946

    Date:_________ _______________________
    Place :_________ ANOOP GOKHALE

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