Gauri M.
Validation Scientist at Genetic Signatures- Claim this Profile
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English -
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Hindi -
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Marathi -
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Bio
Experience
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Genetic Signatures
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Biotechnology Research
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1 - 100 Employee
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Validation Scientist
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Oct 2021 - Present
• Schedule and create validation protocols related to manufacturing, equipment and automated platform for molecular diagnostic kits • Generate study protocols and scientific reports and ensure compliance with regulations, quality practices and proper documentations prior to testing • Design and perform controlled validation studies to support regulatory submissions • Liaise with R&D, QA and Manufacturing team when required to maintain appropriate safety, traceability and quality requirements • Document and maintain test results (Electronic Lab Books, raw data, analysed data reports etc) in accordance with ISO13485 and GLP requirements • Liaise with Regulatory Affairs Manager to ensure all activities comply with QMS and regulatory requirements (including FDA, TGA, CE, HC and IVDR) • Assist with CAPA investigations as required Show less
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Education
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2013 - 2019
Massey University
Doctor of Philosophy - PhD -
2008 - 2010
Anand Agricultural University
Masters of Veterinary Science -
2003 - 2008
Maharashtra Animal and Fishery Sciences University
Bachelor of Veterinary Science -
1991 - 2000
Jawarhalal Nehru Port Vidyalaya
High school
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