FNU SWATI
Hauppauge,NY
Summary
Dedicated Quality Control Specialist with over 8 years of experience in the pharmaceutical industry. Skilled in HPLC analysis, and ensuring product quality and compliance with regulatory standards.
Overview
9
9
years of professional experience
Work History
Chemist
LNK International
Hauppauge, United States
10.2023 - 01.2025
- Optimize and validate chromatographic methods for assay and related substances.
- Conduct routine analytical testing of raw materials and finished products.
- Ensure facility and product compliance with regulatory standards.
- Collaborated with a cross-functional team for method transfer.
- Maintain compliance with cGMP quality systems, and assist in internal audits.
- Handling investigation, deviation, change control, and CAPA.
- Preparation and review of SOPs, validation protocols, and reports.
Assosciate Scientist
Novitium Pharma
East Windsor, United States
05.2022 - 10.2023
- Optimize and validate chromatographic methods for assay, dissolution, and cleaning validation.
- Conduct routine analytical testing of raw materials and in-process products for assay, dissolution, and related substances analysis.
- Water content determination by Karl Fischer. Loss of drying.
- Perform stability testing as per regulatory standards.
- Maintain compliance with cGMP quality systems, and assist in internal audits.
Senior Research Associate
Syngene International
Bengaluru, India
01.2022 - 05.2022
- Method development and validation to evaluate the potency of biologics, as per regulatory standards.
- Analysis of potency and impurities for routine in-process samples as per standard procedures.
- Preparation and review of protocols and reports.
- Maintain compliance with cGMP quality systems, and assist in internal audits.
Scientific Assistant
Zydus Research Center
Ahmedabad, India
02.2018 - 12.2021
- PK and immunogenicity assessment (method validation and study) of large molecules using HPLC and ELISA.
- Collaborated with a cross-functional team for method transfer.
- Maintain compliance with GCP and GLP quality systems, and assist in internal audits.
- Handling investigation, deviation, change control, and CAPA.
- Preparation and review of SOPs, validation protocols, and reports.
Research Biologist
NxGenBio Lifesciences
Delhi, India
04.2016 - 02.2018
- Genetic Sequencing: Handling of Sample Preparation.
- Agarose gel electrophoresis is used to separate nucleic acids.
DBT sponsored BCIL Trainee
HETERO
Hyderābād, India
10.2016
- Stability assessment of large molecules using HPLC, SDS-PAGE, and UV spectrophotometry, as per ICH guidelines.
- Maintain compliance with cGMP quality systems, and assist in internal audits.
Education
M. Sc - Biotechnology
Ch. Charan Singh University
Meerut, IndiaB. Sc - Biotechnology
Ch. Charan Singh University
Meerut, IndiaSkills
- HPLC
- UV-Spectrophotometry
- Karl Fischer
- ELISA
- LOD
- OOS
- Quality management systems
- Good manufacturing practice
- Good laboratory practice
- CAPA
- Attention to detail
- Root cause analysis
- Adaptability
- Collaboration
Awards
- Best Collaborative Alliance Award, Zydus Research Center, Ahmedabad, IN, 2021
- Best Collaborative Alliance Award, Zydus Research Center, Ahmedabad, IN, 2019
- Best oral presentation, International symposium, BHU, Varansi, India, 2015
Personal Information
Visa Status: Valid H1B visa
Accomplishments
- Best Collaborative Alliance Award, Issued by Zydus Cadila · Nov 2021
- Best Collaborative Alliance Award, Issued by Zydus Cadila · Nov 2021
- Best Collaborative Alliance Award, Issued by Zydus Cadila · Nov 2019
- Best Collaborative Alliance Award, Issued by Zydus Cadila · Nov 2018
- Best Collaborative Alliance Award, Issued by Zydus Cadila · Nov 2018
- Best Oral Presentation Award, Issued by IIT-BHU in International conf, SEDER · Feb 2015
Timeline
Chemist
LNK International
10.2023 - 01.2025
Assosciate Scientist
Novitium Pharma
05.2022 - 10.2023
Senior Research Associate
Syngene International
01.2022 - 05.2022
Scientific Assistant
Zydus Research Center
02.2018 - 12.2021
DBT sponsored BCIL Trainee
HETERO
10.2016
Research Biologist
NxGenBio Lifesciences
04.2016 - 02.2018
M. Sc - Biotechnology
Ch. Charan Singh University
B. Sc - Biotechnology
Ch. Charan Singh University
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