Mandar Fonde

Senior Executive at Pinnacle Life Science Pvt. Ltd (Subsidiary of Aarti Drugs)
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Executive
      • Aug 2023 - Present

      Sr. Executive in DQA department Sr. Executive in DQA department

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Research associate
      • Mar 2021 - Aug 2023

    • Quality Assurance Officer
      • Feb 2019 - Mar 2021

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Executive
      • Apr 2018 - Feb 2019

      • Creation, change of BOM and material master in SAP system. • To Prepare and Review Inprocess, Finished product and Stability specifications and Standard test procedures for Regulatory market for Solid and Liquid dosage formulations. • To Prepare and Review API, Excipient material specifications and STPs for Regulatory market. • To review Master formula cards, Master packaging records. • Approval of Change controls for Vendor specifications and STPs. • To handle vendor related technical regulatory documents including DMFs, Stability data, Declarations like Residual solvents, Elemental impurities, TSE/BSE, GMO, LOA, CDA. • Issuance, Distribution, Control and Accountability of Quality documents like Specifications, Protocols, Reports, SOPs. • To Upload specification in SAP system. Show less

  • FDC pvt Ltd
    • raigad, maharastra
    • Quality Assurance Officer
      • Jun 2015 - Apr 2018

      • Handling of SAP system.(Version:- ECC 6.0 incl. EhP7) • Preparation of GMP documents (SOP’s, Specification, Protocols etc) • QA Issuance & Retrieval of various documents i.e. Batch manufacturing Record (BMR) and Equipment Cleaning Record (ECR), log Books for all departments. • Issuance records of Product labels & Seals Checking of material, Labels and Packing as per packing list releasing for dispatch. • Review BMR and BPR and QC protocols, reports. • To provide Quality training, Induction, Job responsibilities, Analyst qualification for new employees training records and maintain training file of all persons in quality of the company. • Maintain equipment and instrument logbooks. • Preparing annual product quality report (APQR). • Handing change control and market complaint with seniors as a team member. • Take QA round for plants and check all activity like critical process parameters, online record filled, housekeeping and any GMP violation. • Knowledge about validation, deviations, OOS, OOT and change controls as per current regulatory requirement. Show less

Education

  • Dr.babasaheb Ambekar college mahad
    M.Sc, Chemistry
    2012 - 2014

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