Sourav Timilsina
Quality Assurance Manager at Nature's Care Manufacture Pty Limited- Claim this Profile
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Bio
Experience
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Nature's Care Manufacture Pty Limited
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Australia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality Assurance Manager
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Feb 2020 - Present
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Natures's care- healthy care Australia
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Sydney, Australia
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Asst. Quality Assurance Manager
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Nov 2016 - Feb 2020
GAP Analysis GAP Analysis
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Nature's Care- Healthy care Australia
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5 Minna Close, Sydney
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Quality Assurance
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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
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AUSTRALIAN PHARMACEUTICAL MANUFACTURERS PTY LTD
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Melbourne, Australia
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Quality assurance and validation Engineer
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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)
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General Mills
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United States
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Manufacturing
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700 & Above Employee
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Project Intern
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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.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Industry based project
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Oct 2013 - Oct 2013
Technological Evaluation for Advanced Aseptic BFS (Blow/Fill/Seal) machine Technological Evaluation for Advanced Aseptic BFS (Blow/Fill/Seal) machine
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Production Executive, QA Associate
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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.
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Education
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Swinburne University of Technology
Master of Science ( Good Manufacturing Practice and Quality Management) -
School of Health and Allied Science, Pokhara University . Nepal
Bachelor in Pharmaceutical Sciences -
Swinburne University of Technology
Good Manufacturing Practice and Quality Management