Shruti Bhargava

7 Year Lifescience exp in QA/QC Biotech Industry

Technology / Internet

Wakad, Pune

About Shruti Bhargava:

7 years of experience in Quality Control & Quality Assurance Biosimilars/ Biotech Industry.
Bioassays, Investigations and root cause analysis using 5-WHY,FMEA,6-M
Data Gather, Data Cleansing and Data Analysis using PLA and Gen 5.
Data Analysis produced by UV –Vis spectrophotometer using Lab Solution to get details about protein concentration.
Data Analysis of Chromatographic data produced by Chromeleon.
Possessing first rate communication and collaboration skills
Team Lead as well as Team player to achieve organizational goals.

Experience

Industry Experience:

Lupin Ltd. Oct 2023 till date

Biotechnology Division,

Pune, Maharashtra, India

Designation – Executive, Quality Assurance

Key responsibilities –

Performing investigations and root cause analysis – Laboratory incidents, Deviations, Out-of-specifications
Preparation and review of investigation reports
Implementing suitable corrective and preventive actions (CAPA) and its effectiveness monitoring
Mentoring and guiding new joiners for smooth onboarding – Certified Buddy
Review of data generated in Quality control department with respect to compliance with ALCOA principles
Review of system audit trails and data compliance
Review of method transfer and method validation data and related activities
Review of batch analytical data, SOPs, EOPs, STPs
Usage of investigation tools like Ishikawa diagram, Why-Why analysis, FMEA
Quality risk assessment – Prospective and retrospective
Quality risk management - Risk scoring and mitigation plans
Implementation of LIMS (Laboratory information management system) at Quality control
Pioneering Right first time (RFT) implementation at Quality control and at plant
Conducting Gemba walks
Facing regulatory audits, Guiding and assisting in regulatory audit compliance – US-FDA, EMA, Health Canada, CDSCO, PMDA, Saudi Arabia, Mexico, Russia, ROW, Partner audits

Lupin Ltd. Feb 2020 to Sep 2023

Biotechnology Division,

Pune, Maharashtra, India

Designation – Executive, Quality Control – Bioassay and Analytical sections

Key responsibilities –

Executing cell-based Bioassays for commercial product release
Product shelf life assessments (Stability testing) at different storage conditions using cell-based bioassay
Extensive cell-bank management and key reagent preparation and management
Maintaining and working with suspended and adherent cell-lines
Interpreting day-to-day analytical data by using biostatistics to verify if the product meets the set specifications
Analyzing and troubleshooting problems in day-to-day analyses
Tracking assay trends to review the assay performance
Working in accordance with GLP, GMP and GDP (Good documentation practices)
Preparation of SOPs, EOPs, STPs (Standard Test Protocol)
Audit preparation, record keeping and data reviews
Working in collaboration with other departments to carryout experiments- Method transfer and method validation
CSV(Computer system validation) of PLA 3.0 and Gen5 software used in routine bio statistical data analysis
Implementing sample status tracker and QAMS tracker in the Bioassay and analytical laboratories for planning and tracking sample analysis and QAMS activities. This considerably reduced the turnaround time (TAT) in the respective sections
Identifying, initiating, execution and completion of various QAMS actions (Change control, Laboratory investigation, Deviation, OOS) within target date
Preparation and review of various investigation reports
Harmonization and simplification of all the bioassay TDS (Test Data sheet) used for recording routine sample analyses – This reduced the redundancies and sped up the data reporting procedure
Review of logbooks and ensure online entries are being made by all the team members
Preparation and implementation of Technical report and SOP on handling of bioassay test data and assay results in order to bring about harmonization in the result reporting practices for all the assays in bioassay section
Preparation of checklist and training content and executing periodic data review of the software used in the section to be in compliance with ALCOA principles.
Implementation of EDMS (Electronic data management system) in the section for SOPs, EOPs
Guiding, training and assisting other team members in various report preparations, sample analysis and other routine activities
Guiding and training fellow team members for the use of SAP for various activities
Implementation of 5S principles in the section
Review of data – periodic audit trail review
Facing regulatory audits, Guiding and assisting in regulatory audit compliance – US-FDA, EMA, Health Canada, CDSCO, PMDA, Partner audits

Enzene Biosciences Ltd. Sep 2019 – Jan 2020

Pune, Maharashtra, India

Designation – Executive, Quality Control - Bioassay

Key responsibilities –

Method transfer of cell-based Bioassays from R&D to QC
Setup of newly qualified QC Bioassay lab area
Qualification of new equipment in the laboratory
Schedule preparation and work allotment for routine activities
Training of fellow team members and interns
Preparation of SOPs, STPs , method transfer related documents
Interpreting day-to-day analytical data by using biostatistics to verify if the product meets the set specifications
Analyzing and troubleshooting problems in day-to-day analyses
Working in accordance with GLP, GMP and GDP (Good documentation practices)

Dr. Reddy’s Laboratories Ltd. Dec 2016 - May 2017

Biologics Development Center,

Hyderabad, Telangana, India

Designation: Assistant Manager, Quality Control - Bioassay

Key responsibilities –

Executing cell-based Bioassays for commercial product release
Product shelf life assessments (Stability testing) at different storage conditions using cell-based bioassays
Procuring key reagents for the department by raising indents and purchase orders using SAP
Extensive cell-bank management and key reagent preparation and management
Maintaining and working with suspended cell-lines
Interpreting day-to-day analytical data by using biostatistics to verify if the product meets the set specifications
Analyzing and troubleshooting problems in day-to-day analyses
Tracking assay trends to review the assay performance
Working in accordance with GLP, GMP and GDP (Good documentation practices)
Preparation of SOPs, STPs (Standard Test Protocol) and JSAs (Job Safety Analysis)
Audit preparation, record keeping and data sheet and ROA(Record Of Analysis) reviews
Working in collaboration with other departments to carryout experiments
Poster Presentation on “OOS investigation: Statistical analysis during method validation” – the purpose of the study was to investigate if Cpk (Process capability index) during bioassay method validation along with assay invalid information can be used to predict the assay variability and probability of obtaining OOS/OOT results during routine testing.

Dr. Reddy’s Laboratories Ltd. Aug 2013-April 2015

Biologics Development Center,

Hyderabad, Telangana, India

Designation: Assistant Manager, Quality Control - Bioassay

Key responsibilities –

Executing cell-based Bioassays for commercial product release
Raw material testing using product specific CHO (Chinese Hamster Ovary) cells which are used in the manufacturing of biosimilars – Growth Promotion Test
Extensive cell-bank management and key reagent preparation and management
Maintaining and working with adherent and suspended cell-lines
Interpreting day-to-day analytical data by using biostatistics to verify if the product meets the set specifications
Analyzing and troubleshooting problems in day-to-day analyses
Tracking assay trends to review the assay performance
Working in accordance with GLP, GMP and GDP (Good documentation practices)
Preparation of SOPs, STPs (Standard Test Protocol) and JSAs (Job Safety Analysis)
Involved in training project intern and team members
Working in collaboration with other departments to carryout experiments
Periodic presentations to different cross-functional teams for product and assay review