Sourav Timilsina

Quality Assurance Manager at Nature's Care Manufacture Pty Limited
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Contact Information
us****@****om
(386) 825-5501
Location
AU

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Experience

    • Australia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Manager
      • Feb 2020 - Present

    • Asst. Quality Assurance Manager
      • Nov 2016 - Feb 2020

      GAP Analysis GAP Analysis

    • Quality Assurance
      • Apr 2016 - Nov 2016

      APQR, Complaint investigation, Risk Assessment SOP's CAPA Process Deviation management HACCP Supplier Qualification FMEA APQR, Complaint investigation, Risk Assessment SOP's CAPA Process Deviation management HACCP Supplier Qualification FMEA

    • Quality assurance and validation Engineer
      • Jul 2015 - Apr 2016

      As a Quality Assurance and Validation Specialist, responsible for : a. Annual Product Quality Review (APQR) b. Stability study design c. Validation (Process validation, Retrospective validation and Cleaning validation) d. Documentation (SOPs, OI's) e. Continuous Process Improvement (CAPA, Change Control and Process Deviation management) f. Equipment Qualification (IQ/OQ) As a Quality Assurance and Validation Specialist, responsible for : a. Annual Product Quality Review (APQR) b. Stability study design c. Validation (Process validation, Retrospective validation and Cleaning validation) d. Documentation (SOPs, OI's) e. Continuous Process Improvement (CAPA, Change Control and Process Deviation management) f. Equipment Qualification (IQ/OQ)

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Project Intern
      • Aug 2014 - Nov 2014

      Project: Temperature Mapping and Validation throughout the manufacturing process to ensure the required final product temperature. Project: Temperature Mapping and Validation throughout the manufacturing process to ensure the required final product temperature.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Industry based project
      • Oct 2013 - Oct 2013

      Technological Evaluation for Advanced Aseptic BFS (Blow/Fill/Seal) machine Technological Evaluation for Advanced Aseptic BFS (Blow/Fill/Seal) machine

    • Production Executive, QA Associate
      • 2009 - 2012

      • Designing the formulation trial for solid dosage forms and escalating it till commercial batch. • Developing analytical methods for quality control test of RnD products. • Prepare the document required for regulatory submission in order to get marketing authorization of those products. • Conducting training on GMP requirements. • Preparing and developing SOP’s, SMF, QMP . • Review Batch Manufacturing Record (BMR) and quality test reports before releasing the product. • Initiating Root cause analysis for any deviation occurring and proposing Corrective and Preventative Action (CAPA) for those deviations.

Education

  • Swinburne University of Technology
    Master of Science ( Good Manufacturing Practice and Quality Management)
    2013 - 2015
  • School of Health and Allied Science, Pokhara University . Nepal
    Bachelor in Pharmaceutical Sciences
    2005 - 2009
  • Swinburne University of Technology
    Good Manufacturing Practice and Quality Management

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