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    Covering Letter: S.No Client/Project Name Location Support

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    Rambo
    The candidate has over 20 years of experience in commissioning, qualification, and validation roles in the pharmaceutical and biotechnology industries. He has successfully led commissioning, qualification, and validation projects for several companies in India and abroad. The candidate's expertise includes developing validation lifecycle documentation, qualification protocols, and ensuring compliance with regulatory standards. He holds an advanced degree in quality management and seeks contract roles leading commissioning, qualification, and validation assignments.

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    Covering Letter: S.No Client/Project Name Location Support

    Uploaded by

    Rambo
    45 views1 page
    The candidate has over 20 years of experience in commissioning, qualification, and validation roles in the pharmaceutical and biotechnology industries. He has successfully led commissioning, qualification, and validation projects for several companies in India and abroad. The candidate's expertise includes developing validation lifecycle documentation, qualification protocols, and ensuring compliance with regulatory standards. He holds an advanced degree in quality management and seeks contract roles leading commissioning, qualification, and validation assignments.

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    brief covering letter

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    Brief Covering Letter 16 05 2019

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    The candidate has over 20 years of experience in commissioning, qualification, and validation roles in the pharmaceutical and biotechnology industries. He has successfully led commissioning, qualification, and validation projects for several companies in India and abroad. The candidate's expertise includes developing validation lifecycle documentation, qualification protocols, and ensuring compliance with regulatory standards. He holds an advanced degree in quality management and seeks contract roles leading commissioning, qualification, and validation assignments.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    45 views1 page

    Covering Letter: S.No Client/Project Name Location Support

    Uploaded by

    Rambo
    The candidate has over 20 years of experience in commissioning, qualification, and validation roles in the pharmaceutical and biotechnology industries. He has successfully led commissioning, qualification, and validation projects for several companies in India and abroad. The candidate's expertise includes developing validation lifecycle documentation, qualification protocols, and ensuring compliance with regulatory standards. He holds an advanced degree in quality management and seeks contract roles leading commissioning, qualification, and validation assignments.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Covering Letter

    My skills and expertise would be ideally suitable for overall implementation and undertaking of
    Commissioning, Qualification & Validation (CQV) assignments/projects of New/existing Pharma/Life
    Science/Biotech.

    Having over 20 years of experience in Commissioning, Qualification and Validation, Mechanical and
    Process areas of reputed Pharma, Biotechnology, Vaccine manufacturing, Sterile APIs and other
    GMP/Engineering consultancy organizations in India and abroad.

    Successful accomplishment for the following projects in contract role :


    S.No Client/Project Name Location Support
    Merck Biologicals Project(Kartik) at BE
    01. Hyderabad,India Overall CQV)
    Ltd New Facility
    Adcock Ingram High Volume Liquid
    02. South Africa C&Q
    Orals Facility
    03. Prime Biologics Singapore C&Q – Process Equipment
    Hospira(Pfizer) Sterile Injectable
    04. Vizag, India Overall CQV – 2 suites
    Manufacturing New Facility
    Systacare Remedies, Renovated QMS Remediation &
    05. Amritsar, India
    Sterile Injectable Facility Validation Support
    Overall C&Q
    06. Givaudan Peshwa, New facility Pune, India
    Also, I had significantly contributed my skills and expertise by employing directly with reputed
    companies including M/S Cadila Pharma Ltd; M/S Indian Immunologicals Ltd; M/S Aurobindo Pharma
    Ltd; M/S Akums Drugs & Pharma Ltd, M/S Syngene International Ltd; M/S Reliance Life Sciences pvt
    Ltd; M/S Dr.Reddy's Laboratories Ltd; and M/S Cipla Ltd handling various formulations.

    Graduated in Pharmaceutical Science from Mangalore University and Post Graduated (MS in Quality
    Management) from BITS, Pilani.

    Key Strengths:

     Adept in implementation of Latest Commissioning & Qualification Methodologies


     Development of Policies, Commissioning, Qualification and Validation Master Plans.
     Establishment of Validation Life Cycle Documentation as per ISPE, GAMP, ASME, ASTM etc.
     Identification and generation of User Requirement Specification(URS) and compliance
    verification
     System and Component Level Impact Assessment (CLIA) and development of system
    boundaries (SLIA) for criticality.
     Critical Review and compliance to Design Qualification(DQ), Factory Acceptance Test(FAT),
    Site Acceptance Test(SAT), Turn Over Package(TOP) documentation
     Development of Quality Assurance Programme(QAP) and Inspection Test Plans(ITP)
     Witness, compliance, and certify the FAT & SAT documentation
     Generation of Traceability Test Matrices
     Write and execute Installation, Operational (IOQ), and Performance Qualification(PQ) protocols
    and summary reports for equipment and systems
     Identify and drafting the Standard Operating procedures(SOP) and PM Schedules
     Development of Process Flow Charts and Master Batch Records and Conducting Process
    Validation (PV) Studies
     Development of Sterile Assurance Validation protocols (Process Simulations) and their
    execution
     Development of cleaning strategy/cycles and Carrying out Cleaning Validation (CV) Studies
    (CIP/SIP).
     Timely accomplishment of Targeted Deliverables.
    Thanking you in anticipation.

    Kind Regards,
    D.Ramesh Babu
    Freelancer – CQV Engineer/Manager
    Validation & Quality Management
    242/3RT/1 l Masab Tank l Hyderabad - 500057 l India
    M: +91-7032597309(WhatsApp) l +91-8008634796
    Email: [email protected]

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