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    Rajkumar Jha

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    Anurag Singh
    RAJKUMAR JHA

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    Rajkumar Jha

    Uploaded by

    Anurag Singh
    11 views2 pages
    RAJKUMAR JHA

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    RAJKUMAR JHA

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    RAJKUMAR JHA

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    11 views2 pages

    Rajkumar Jha

    Uploaded by

    Anurag Singh
    RAJKUMAR JHA

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    R RAJKUMAR JHA

    Position: General Manager Technical


    Company: ADLEY FORMULATIONS PVT. LTD.
    Location: Sikkim, India
    Experience: 22 years exp

    Cont act Inf o:


    Email: [email protected]

    Social:

    Skills
    21 CFR Part 11 Analytical Chemistry ANDA Approved Technical Person For CHEMICAL & INSTRUMENTAL

    AS WELL AS MICROBIOLOGICAL TESTING Auditing By FDA MAHARASHTRA THANE CAPA Change Control

    Cleaning Validation Continuous Improvement Deviations Environmental Management Systems FDA

    Formulation Generic Programming GLP GMP HPLC ISO ISO 9001

    Laboratory Information Management System (LIMS) Laboratory Skills Manufacturing Operations

    Manufacturing Operations Management Manufacturing Process Improvement Pharmaceutical Industry

    Pharmaceutical Plants Operations Pharmaceuticals formulation Plant Operations Quality Assurance

    Quality Auditing Quality Control Quality Improvement Quality Management Quality System

    Regulatory Affairs Regulatory Requirements Regulatory Submissions Software Quality Assurance Sop

    Technology Transfer V&V Validation Water Quality

    Work experience
    Mar 2024 - current time General Manager Technical
    ADLEY FORMULATIONS PVT. LTD.
    Overall responsible for Productivity with Quality
    Feb 2024 - current time Quality Head
    Maxtar Bio-Genics
    Skills: Manufacturing Operations · Pharmaceutical Plants Operations ·
    Manufacturing Operations Management · Formulation · Auditing · Water Quality ·
    Environmental Management Systems · Continuous Improvement · Quality
    Improvement
    Jan 2021 - Jan 2024 Site Quality Head
    Alembic Pharmaceuticals Limited
    Skills: Analytical Chemistry · Manufacturing Operations · Manufacturing
    Operations Management · Formulation · Auditing · Quality Management · Water
    Quality · Environmental Management Systems · Continuous Improvement ·
    Quality Improvement
    Jan 2021 - Jan 2024 Site Quality Head
    Alembic Pharmaceuticals Limited
    Skills: Manufacturing Operations · Manufacturing Operations Management ·
    Software Quality Assurance · Formulation · Auditing · Quality Management ·
    Water Quality · Environmental Management Systems · Continuous Improvement ·
    Quality Improvement
    Mar 2018 - Jan 2021 Site QA HEAD
    Aristo Pharmaceuticals Pvt. Ltd.
    Over all responsible for execution of QMS at SITE
    Jun 2012 - Mar 2018 Site. Quality Head
    Ipca Laboratories ltd.
    Responsible for execution of QMS system as per cGMP, cGLP & cGDP, cGWP
    May 2012 - Jun 2012 QA/QC head
    Life Line Pharma
    Overall responsible for QMS execution
    Oct 2009 - May 2012 Head Of Quality
    SUN PHARMA SIKKIM
    Managing to maintain the Quality of Product formulated at our Plant by
    implementation and continuous review of existing cGMP concept along with Gap
    Analysis followed by identification and execution of CAPA to upgrade the
    Quality system.
    Feb 2007 - Oct 2009 Dy. Manager - QA
    AKUMS DRUGS & PHARMACEUTICALS LTD
    Handling of SOP,BMR & BPR, Quality system, Change Control, Deviation, IPQA ,
    APR, Self Inspection & Quality Audit, Market Complaint,managed for successfull
    audit and further WHO cGMP & ISO certification for our Injectable Plant along
    with several third party audits of Giant Pharma manufacturers.
    Jan 2006 - Jan 2007 Head QA
    Creative health Care Pvt. Ltd
    Over all responsible to maintain the Quality of Product being formulated at our
    Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
    Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
    Complaint,managed for successfull audit of several third party audits of Pharma
    Companies like CIPLA, Glenmark etc.
    Jan 2004 - Jan 2006 Head Quality
    Lesanto laboratories
    Over all responsible to maintain the Quality of Product being formulated at our
    Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
    Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
    Complaint,managed for successfull audit and further WHO cGMP Certification
    for our Plant along with several third party audits of Pharma Exporters.
    Mar 2003 - Jul 2004 QA MANAGER
    Ronilo Pharma Pvt. ltd.
    Over all responsible to maintain the Quality of Product being formulated at our
    Plant followed by Handling of SOP,BMR & BPR, Quality system, Change Control,
    Deviation, IPQA , APR, Self Inspection & Quality Audit, Market
    Complaint,managed for successfull audit faced several third party audits of
    Pharma Exporters.

    Educat ion
    1990 - 1992 CHEMISTRY WITH SPECILISATION IN PHYSICAL CHEMISTRY
    MASTER OF SCIENCE
    B.N.MANDAL UNIVERSITY MADHEPURA, BIHAR
    1990 - 1992 Chemistry
    Master of Science - MS
    BNM University Mafhepura
    1987 - 1990 CHEMISRTY(HONOURSE) WITH BOTANY & Z OOLOGY
    BATCHELOR OF SCIENCE
    BHAGALPUR UNIVERSITY, BHAGALPUR

    Head line
    Plant Operations

    Summary
    I have Educational, technical & managerial experience and sound knowledge for heading QC,QA,
    Regulatory,Operational activity of Pharmaceutical Manufacturing company either jointly. Well experienced in OSD,
    Liquid, External Preparation, SVP, LVP,PFS. Dry Powders, Sterile n No sterile both types formulations Plant.

    Languages
    Marathi,Gujarati,

    Project s
    lab set up at various previous organisation

    Cert if icat ions


    Approved Technical Person for Chemical, instrumental & Microbiological Testing from FDA Thane MAharashtra

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