Quality Control Change
Resume:
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PRASHANTI SAMANTA
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Jigani,Bengaluru,560105 DOB-25/02/1997
Continuing
Objective
Seeking a challenging position in industry where I can leverage my 4 years of experience to contribute to innovative solutions, drive project success, and further develop my professional skills in a dynamic and growth oriented environment.
Experience
Syngene international Limited
Quality Control Executive
Extensively involved in protocol preparation to data compilation for steam sterilizer performance qualification and re-qualification as an user requirements specification. Leading and participating in cross functional teams to ensure validation activities completed on time and to the highest standards.
Hands on experience in biological indicator enumeration test. Having adequate knowledge of Pharma Regulatory Guidelines such as USFDA 21 CFR Part 11, EU GMP Annex 11,21CFR subpart D,V model.
Initiation of the discrepancies/CAPA/change control during any of the qualification activities and during routine operations.Reporting and investigation of lab incidence and deviation.
Media receipt,preparation and stock maintenance in LIMS and growth promotion test for all received and prepared media.Balance and pH meter daily and monthly calibration. Bioball receipt, enumeration and storage.Culture suspension preparation and maintenance for routine usage.
Adherence to safety policy during regular activities. Labware LIMS and ELN sheet usage for various microbial test. Strong Expertise in GxP Regulatory requirements, Good Documentation Practices and cleanroom requirements.
Document issuance and archival of documents.
Mar 2023 - Dec
2023
Aug 2021 - March
2023
Dr Reddy's laboratories Ltd
Quality Control Associate
Autoclave performance qualification and re qualification as per schedule Verification of Ready to use media and selective stock and arrangement for daily activity Indent request for Ready to use media and dehydrated media.Media labelling,media pH preincubation,GPT in LIMS and expired media decomposition through LIMS Growth promotion test for Ready to use media
Preparation of culture suspension for EM isolate and Water isolate Handling of Bioballs and rehydration fluids
Identification of microorganisms by Previ Color Gram and preparation of Microbial Library
Disinfectant preparation and filtration (Bacillocid and minncare) Inoculation and observation of Biological Indicators EM plates release and observation and preparation of EM Trends Document issuance and archival procedure
Gland Pharma Limited
Quality Control Chemist
BET test for water samples and finished product by Gel clot Menthod BET Method Validation Protocol and report preparation Growth promotion test for inhouse and ready to use media Preparation of culture suspension for Water isolate and EM isolate Handling and maintenance of bioballs
Hands on practice on autoclave operation
Scheduled Disinfectant preparation
Organism identification by Gram staining
Basic idea about vitek 2 compact operation and cleaning procedure Hands-on experience on Water analysis and Pathogen testing Disinfectant validation thorough surface challenge method Disinfectant efficacy test
pH meter and analytical balance calibration
Pipette calibration
Aug 2020 - Aug
2021
Jan 2019 - June
2019
2019
2017
2014
2012
Promea Therapeutics pvt ltd
Trainee Research Associate
Protein expression checking through SDS Page
pH meter and Balance callibration
Hands on experience on chromatography (Akta pure and Akta pilot) Column packing
DBC checking for column
Preparation of Media and buffer
DNA extraction
Regional Medical Research Centre
Intern
Involved in the research process of "Prevelance, risk factors and morbidities of gestational diabetes mellitus among pregnant women attending a hospital in an urban area of Bhubaneswar,Odisha."
Education
Ramadevi Women's University
M SC Biotechnology
E grade/81%
Khallikote Autonomous College
B Sc
78%
Nayagarh Autonomous college
Intermediate
67%
Radhakanta girl's high school
SSC
85%
Skills
Able to work independently as well as in a team
Time management
Validation
Troubleshooting and investigations
Leadership and decession making
Communication and collaboration
Publications
Prevelance, risk factors and morbidities of gestational diabetes mellitus among pregnant women attending a hospital in an urban area of Bhubaneswar,Odisha.
Activities
Cooking
Playing games
Handmade ornaments
Languages
English
Hindi
Odia
Telugu
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