GLORIYA KUTTIYATH
Pune,INDIA
Summary
Determined, energetic and competent professional with a demonstrated history of working in the various areas of biotechnology industry. With experience of delivering timely Bioanalytical product development activities in peptides. Sound knowledge of drug development, ICH guidelines, SOPs and GLPs. With experience in Medical device regulatory affair and documentation, clinical trial analysis and insight gathering, company product research, conference abstract, ppt and paper interpretation and literature review. Strategic planning to meet timelines, self starter with ability to work in large teams. Strong communicator and research professional with a Biocon-KGI certificate program focused in Biosciences.
Overview
4
4
Certifications
4
4
years of post-secondary education
4
4
years of professional experience
Work History
Engineer
Tata Elxsi
Pune, Maharashtra
08.2020 - Current
- Creating GSSD based on the EU MDR 2017/745 for various Medical Device products like Drug-Device combination, Implants and Device-software combination products.
- Writing content for different sections in GSSD as per EU MDR regulations and product technicalities.
- Preparing STED structure for the medical device.
- Review of the GSSD and STED structure for document quality check for high quality, error free and technically sound document output.
- Reviewed and verified product technical reports and documents like risk documents, PSUR, Product Design and verification documents, product drawings and schematics, packaging drawings and product specification documents for EU MDR compliance and data extraction for GSSD.
- Document organization, management and working knowledge of document repositories like webtop and Agile PLM.
- Preparation of slide decks for new project proposal support and general meeting.
Clinical Research Associate
Ascentrik Research
Pune, Maharashtra
05.2020 - 07.2021
- Searched, summarized and updated the data of clinical trial in database for different drugs and coordinated the changes with on-shore client team.
- Clinical trial search and monitoring in all the major clinical trial registries.
- Screened, collected, interpreted, and summarized data from various international conferences like ASCO, AHS, ASGCT, etc and publications to authenticate and update data for client.
- Conducted company research by analyzing annual reports, quarterly reports and news feeds to identify progress made in terms of new products, trials, and regulatory status of the existing biologic, cell therapies and gene therapy.
- Quality check for the work being done.
Scientist
Biocon Limted
Bangalore, Karnataka
01.2018 - 01.2020
- Managed routine analysis, method qualification and method development activities of final API, In-process samples, raw materials and supported in resolving OOS in laboratory environment for product development purposes of peptide projects.
- Tests performed includes HPLC based Purity, Assay, chiral, content methods, and size exclusion chromatography, moisture Content, LOD, FTIR and forced degradation studies of peptides.
- Prepared product analytical method development and qualification reports, COA and ADS.
- Periodic calibration, maintaining and troubleshooting of HPLC with UV,PDA and FLD detectors and daily calibration of analytical balance and its documents management.
- Capturing daily activities in LBN and updating log books.
- Well versed with ICH guidelines and GLP also knows softwares like Empower, Tiamo and Omincs.
- Simultaneously managed several complex projects, meeting all pertinent milestones assigned individually and as team.
Science Tutor
VICENTA MARIA BOARDING
Mumbai
07.2016 - 02.2017
- Taught Science and technology to 10th Std.
- Provided early intervention assistance to struggling students.
- Motivated students towards learning and studying to build self-confidence and reduce fear of failure.
Education
Master of Science - Life Sciences (Applied Medical Sciences)
St. Xavier’s College
Mumbai 08.2015 - 05.2017
Bachelor of Science - Biotechnology
K.T.H.M. College, Pune University
Nashik 07.2015 - 05.2017
Certification - Biosciences
Biocon Academy - Keck Graduate Institute (KGI)
08.2017 - 12.2017
Skills
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Certification
FDA Bad AD and prescription drug promotional activity certification
Accomplishments
- Presented a review paper at Bangalore Tech Summit
- Participated in Biowaves, DBT sponsored a symposium on at St.Xavier’s College, Mumbai.
- Won the 3rd prize in the Science Exhibition at K.T.H.M. College
Hobbies
- Writing poems
- Blogging (www.medicalknowledge.co.in)
- Reading
- Cooking
Timeline
FDA Bad AD and prescription drug promotional activity certification
03-2021
Engineer
Tata Elxsi
08.2020 - Current
Applied ISO14971 Medical Device Risk Management
08-2020
Clinical Research Associate
Ascentrik Research
05.2020 - 07.2021
Scientist
Biocon Limted
01.2018 - 01.2020
Pilot Scale Fermentation and Downstream Processing
11-2017
Certification - Biosciences
Biocon Academy - Keck Graduate Institute (KGI)
08.2017 - 12.2017
Science Tutor
VICENTA MARIA BOARDING
07.2016 - 02.2017
Practical Training course in handling and use of industrial Analytical Instruments
04-2016
Master of Science - Life Sciences (Applied Medical Sciences)
St. Xavier’s College
08.2015 - 05.2017
Bachelor of Science - Biotechnology
K.T.H.M. College, Pune University
07.2015 - 05.2017
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