Osbert Luis Fernandes
Quality Assurance Specialist at Lotus Labs Pvt Ltd- Claim this Profile
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Bio
Credentials
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Project Management Foundations: Quality
LinkedInJun, 2021- Oct, 2024 -
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
CITI Program, A Division of BRANYApr, 2021- Oct, 2024 -
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
CITI Program, A Division of BRANYApr, 2021- Oct, 2024 -
Biomedical Research
CITI Program, A Division of BRANYMar, 2020- Oct, 2024 -
Biomedical Responsible Conduct of Research
CITI Program, A Division of BRANYMar, 2020- Oct, 2024
Experience
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Lotus Labs Pvt Ltd
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India
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Research Services
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100 - 200 Employee
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Quality Assurance Specialist
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Apr 2018 - Present
•Associated with clinical trials and bioanalysis. •Audited method developments, method validation of various molecules as well as endogenous molecules. •Audited bio-study for regulatory submissions as mentioned below:- • USFDA • EU •Japan •ANVISA •Malaysian •Canada •Audited PK studies for various submissions. •Associated with calibration and validation activities of instruments and equipments. •Performed external vendor audits. •Performed internal audits for various departments. •Part of the events committee at lotus labs and organized various events. •Won best player of the Organization for football. •Winner of the Cricket, Football and volleyball held in the organization. Show less
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Education
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2016 - 2018
Nitte University
Master of pharmacy, Pharmaceutics and Drug Design -
2012 - 2016
MM College Of Pharmacy
Bachelor’s Degree, B.pharm -
DeepVihar High Secondary School
High School, science -
2016 - 2018
Nitte University
Master's degree, Pharmaceutical Sciences
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