Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Tulasi Sama

Summary

QC Analytical professional with 2+ years of experience supporting pharmaceutical manufacturing through analytical testing, method validation, and stability programs in cGMP environments. Proficient in HPLC, UPLC, UV/Vis, FT-IR, dissolution, and Karl Fischer analysis for raw materials, in-process, finished, and stability samples. Experienced in OOS/OOT investigations, regulatory compliance (FDA, ICH, ), and GMP documentation, with demonstrated ability to coordinate laboratory activities to ensure accurate results and on-time product release.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Quality Control Analyst

Catalent Pharma Solutions
Winchester, KY
12.2023 - Current
  • Conducted various quality tests on pharmaceutical products, including in-process materials, Stability and finished goods.
  • Operated various analytical instruments, including HPLC, UPLC, UV spectrophotometer, Karl Fischer titrator, and dissolution apparatus.
  • Executed diverse quality control tests utilizing advanced analytical instruments.
  • Conducted thorough cleaning validation and verification analysis to maintain operational integrity and safety.
  • Documented and reported test results, findings, deviations, and issues using Microsoft applications to ensure traceability and compliance.
  • Assisted with product certification and compliance activities, including audits, testing, and sample submissions.
  • Conducted a variety of analytical assessments to ensure pharmaceutical product quality and consistency.
  • Evaluated final products to ensure compliance with quality standards and meticulously documented test results and findings.
  • Maintained and calibrated laboratory equipment and instruments to ensure the accuracy and reliability of test results and ensured that all quality control activities were carried out in compliance with GMP, GLP, and regulatory guidelines.
  • Ensured precision in maintaining written records for all analyses conducted.
  • Utilized LIMS and Empower software to streamline laboratory processes.
  • Collaborated with laboratory staff to guarantee quality control and meet compliance requirements.
  • Maintained a clean and organized laboratory environment to support accurate testing and analysis through proper chemical handling and storage practices.
  • Led out-of-specification investigations and corrective action preventive action (CAPA) processes.
  • Utilized TrackWise electronic quality management system to document, review, and monitor quality events in a GMP-regulated environment.
  • Executed quality control activities in compliance with GMP, GLP, and regulatory guidelines to uphold testing standards.

Research Assistant

Peptas Pharma
India,
01.2021 - 09.2021

• Collected, received, and labelled samples for analysis.
• Prepared and handled samples, ensuring they are properly stored and documented.
• Operated various analytical instruments including HPLC, Dissolution
• apparatus, sieve analysis and Microscopes.
• Collected data from experiments and Analysis.
• Preparation of graphs, charts, and Tables to present the Findings.
• Collaborated with senior research associates to design experiments and protocols.
• Identified and troubleshooted issues with Analytical Instruments.
• Analyzed and Interpreted data using software tools. Summarized and communicated with
team members regarding research findings.
• Developed effective presentation skills to communicate research findings to colleagues,
and superiors.

Education

Master of Science - Pharmacology And Toxicology

Wright State University
Dayton, OH
05-2023

Bachelor of Science - Pharmacy

Gurunanak Institutions
Hyderabad, IND
08-2021

Skills

  • HPLC/UPLC
  • Karl Fischer
  • FTIR
  • UV-Vis
  • Chromatogrphy Data Systems: Empower
  • Analytical Procedures
  • LIMS
  • Microsoft Office Tools: Power point, Word, Excel

Certification

  • Clinical Trial Co-Ordination Certification Program.
  • Good Clinical Practice-ICH – CITI program
  • Lean Six Sigma Yellow belt certification.

Timeline

Quality Control Analyst

Catalent Pharma Solutions
12.2023 - Current

Research Assistant

Peptas Pharma
01.2021 - 09.2021

Master of Science - Pharmacology And Toxicology

Wright State University

Bachelor of Science - Pharmacy

Gurunanak Institutions