SHIVANGI MISHRA
Nashik
Summary
Motivated and results-oriented professional seeking a challenging role where I can leverage my life science knowledge to contribute to the organization.
Overview
1
1
year of professional experience
Work History
Apprentice - Analytical Documentation - CQA
Glenmark Pharmaceuticals Ltd.
Nashik
06.2024 - Current
- Preparation and review of analytical documents, like specifications, standard test procedures, and test data sheets for raw materials, semi-finished products, and finished products for all sites.
- Responsible for uploading documents and making them effective in OpenText software.
- Responsible for change control initiation, evaluation, and implementation activity (QMS), etc.
- Gap assessment between IP, BP, USP, and Ph. Eur. Pharmacopeia with Glenmark documents (221 Raw material codes reviewed).
- Responsible for the preparation of the Monthly Status Report, to maintain and update Excel files related to RM.
- Authorized to use the SAP module, OpenText, Goose Harmony. Familiar with SAP-related activity (Ex. Read and assess change control for RM-impacted codes, to check AVL,Impacted market list and to confirm material name, code, and plant.
- Coordination with all stakeholders (R&D, RA, CQA) and support requirements. Sent the daily released document status to stakeholders, and coordinated with R&D for the availability of supporting documents (COA, AMV, Justification, etc.) Required for the preparation of specifications.
Education
Master of Science - Biotechnology
K.T.H.M College, SPPU
Nashik, Maharashtra08-2023
Bachelor of Science - Biotechnology
K.C College, University of Mumbai
07-2019
HSC - Science- PCB and CS
Nashik Cambridge School, CBSE
07-2018
Skills
- QA documentation
- Project management
- Pharmacopeial analysis
- SAP module, OpenText software
- Change control management
- Microsoft Office Suite
- Time management
- Organizational skills
- Strong communication skills
- Adaptive
Publication
Awareness, Perception and Usage of Nutraceuticals in Indian Society, International Journal of Scientific Research in Science and Technology (IJSRST), 8, 5, 09/01/21, https://ijsrst.com/paper/8804.pdf
Projects Research Experience
- Evaluating the Potential of Heavy Metal Resistant PGPRs for Bioremediation and Plant Growth Promotion in Solanum Lycopersicum, Department of Biotechnology, K.T.H.M College, Nashik, 08/01/22, 05/31/23
- Awareness, Perception and Usage of Nutraceuticals in Indian Society, Department of Biotechnology, K.C College, Mumbai, 08/01/20, 05/31/21, IJSRST journal
Certificates Extra Curricular
- FOSTAC’s Food Safety Supervisor training course on Advance Manufacturing and COVID under FSSAI.
- Food Safety and standards (Packaging, labelling and display) Regulations 2018;2020.
- UGC College level Avishkar-2022 Research Competition.
- Udemy certificate course on 'Genetics and Next Generation Sequencing for Bioinformatics'.
Timeline
Apprentice - Analytical Documentation - CQA
Glenmark Pharmaceuticals Ltd.
06.2024 - Current
Master of Science - Biotechnology
K.T.H.M College, SPPU
Bachelor of Science - Biotechnology
K.C College, University of Mumbai
HSC - Science- PCB and CS
Nashik Cambridge School, CBSE
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