Summary
Overview
Work history
Education
Skills
Languages
Personal Information
Instrument Expertise
Accomplishments
References
Timeline
Generic

Sujata Surendra Yadav

Marunji,India

Summary

A results-oriented professional with expertise in executive presentation and results dissemination, demonstrating thoroughness and innovative thinking. Skilled in audit data analysis and quality control tools usage, ensuring adherence to regulatory standards and maintaining quality consciousness. Committed to creative innovation, aiming to leverage core competencies for impactful contributions in future roles.

Overview

20
20
years of professional experience

Work history

Executive (QC Stability/ Finished Product/ AMV)

EMCURE
Pune
10.2020 - 05.2025
  • QC Stability
  • Analytical method validation/verification data review for adequacy & accuracy for in-house and outsource projects for finished products.
  • Overseeing and executing stability studies to determine the shelf life and long-term quality of pharmaceutical products.
  • Planning, Scheduling and monitoring the execution of routine work within stipulated period of time.
  • Testing samples, Documenting results, Preparing reports.
  • Good knowledge of GMP, GLP, GDP and Data Integrity.
  • Ensure compliance with GMP, ICH guidelines, and other relevant regulations.
  • Analysis of Finished Product
  • Quality control and assurance of final products, ensuring they meet specifications and standards before release to the market.
  • Testing and Analysis using HPLC, Dissolution apparatus.
  • Documentation.
  • Collaboration with other departments to maintain product quality.
  • Analytical Method Validation (AMV)
  • Ensuring analytical methods used in a laboratory are accurate, reliable, and fit for purpose.
  • Perform validation studies.
  • Documenting the results.
  • Ensuring compliance with regulations like cGMP and GLP.
  • Troubleshooting issues with methods.
  • Providing training to other staff.
  • Quality Management System (QMS)- Training Co-Ordinator.
  • Training Development and Delivery.
  • Needs Assessment.
  • Program Management.
  • Evaluation and Improvement.
  • Documentation and Reporting.
  • Collaboration.
  • Continuous Improvement.

Research officer/Executive (ANDA)

EMCURE
Pune
06.2008 - 01.2011
  • Analytical Method Development, Validation & Method Transfer.
  • Analytical method validation/verification data review for adequacy & accuracy for in-house and outsource projects for finished products, API's and excipients.
  • Complete Analytical Method Validation and Method transfer activity as per timelines.
  • Review method equivalency data, protocols, reports and calculation sheets of validation, investigation protocols and reports, and method comparison report.
  • Assay related substances and dissolution analysis of stability samples of FP.
  • Classical & instrumental Analysis of stability samples of API.
  • Prepare stability protocol and schedule.
  • Maintain GLP system in the Laboratory.
  • Calibrate instruments as per calibration schedule.
  • Sampling of finished products and row material.
  • R&D analysis of row material, tablets & capsules for content uniformity, assay & dissolution test.

Research Associate(NDDS)

SUN PHARMA
Mumbai
03.2005 - 12.2007
  • Analytical method development & validation.
  • Performed Analytical method validation / verification data review for adequacy & Accuracy for in-house & Pharmacopeia projects for finished products, API's and excipients.
  • Reviewed analytical raw data of finished product batches of US & UK before batch release for adequacy & Accuracy.
  • Reviewed electronic raw data and Audi trials review of HPLC, GC, UV, IR, Autotitrator, Dissolution for Compliance purpose.
  • Assay related substances & dissolution analysis of stability samples of FP.
  • Performed classical & instrumental analysis of stability samples of API.
  • Prepared stability protocols & schedule.
  • Maintained the GLP System in Laboratory.
  • Performed calibration of instruments as per calibration schedule.

Education

Certification course - Clinical Research

Clini India

M.Sc. - Analytical Chemistry

Bharati vidyapeeth Department of Chemistry

B.Sc. - Chemistry

A.M College

MS–CIT - undefined

Maharashtra State Certificate Course in Information Technology

Skills

  • Executive presentation
  • Results dissemination
  • Thoroughness
  • Innovative thinking
  • Knowledge of regulatory standards
  • Audit data analysis
  • Creative innovation
  • Result-Oriented approach
  • Quality consciousness
  • Quality control tools usage

Languages

Marathi
Hindi
English

Personal Information

  • Date of birth: 07/30/81
  • Gender: Female
  • Nationality: Indian
  • Marital status: Married
  • Religion: Hindu

Instrument Expertise

  • HPLC–Agilent, Shimadzu (with LC solution & chromoleon software), waters (Waters Alliance W2695 & W2996 PDA, Separation module with Empower 3-0 software), TSP.
  • UV Spectrophotometer – Shimadzu (Model UV-1800), Perkin Elmer (Model lambda 35).
  • IR – Shimadzu.
  • KF-Titrator & Autotitrator-Metro Hams (Make: Metrohm, 794 basic Titrino, 703 Tistand pad).
  • Polari meter (Make: Rudhalph), pH meter.
  • Dissolution tester, D.T. apparatus, Friability tester-Electro lab.
  • Particle size analyzer – Malvern.
  • Capillary Electrophoresis-Agilent.
  • Ion Chromatography- Metro Hams.

Accomplishments

Received award and recognition

References

References available upon request.

Timeline

Executive (QC Stability/ Finished Product/ AMV)

EMCURE
10.2020 - 05.2025

Research officer/Executive (ANDA)

EMCURE
06.2008 - 01.2011

Research Associate(NDDS)

SUN PHARMA
03.2005 - 12.2007

M.Sc. - Analytical Chemistry

Bharati vidyapeeth Department of Chemistry

B.Sc. - Chemistry

A.M College

MS–CIT - undefined

Maharashtra State Certificate Course in Information Technology

Certification course - Clinical Research

Clini India

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Sujata Surendra Yadav