Quality Control Systems

Parjanya Varma Patsamatla

Phone: +1-551-***-**** Email: ******************@*****.***

Linkden: https://bit.ly/3ODMReD

Executive Summary

Enthusiastic Analytical Chemist with over 3 years of experience in HPLC, UV Spectroscopy, Metrohm Autotitrator, SOR Analysis, and sample preparation. Proficient in data analysis, method development, and ensuring compliance with FDA cGMP standards. Demonstrated a 25% improvement in analytical accuracy and led projects that reduced data reporting time by 30%.

EDUCATION

New Jersey Institute of Technology (New Jersey, USA) 2024

M.S., Pharmaceutical Systems Management

•Focused on quality systems, regulatory compliance, and pharmaceutical manufacturing operations, developing proficiency in management, FDA cGMP regulations, and process improvement methodologies.

•Specialized in engineering cost analysis, production economics, and pharmaceutical packaging, with expertise in optimizing production processes and packaging solutions for pharmaceutical products.

Krishna University (India) 2019

M.Sc., Analytical Chemistry

•Specialized in advanced analytical techniques such as HPLC, UV-Vis spectroscopy, and chromatography.

•Focused on quantitative analysis and the development of methods for pharmaceutical applications.

Adikavi Nannaya University (India) 2016

B.Sc. Botany, Zoology, and Chemistry

•Conducted comprehensive studies in Botany, focusing on plant physiology, classification, and ecological interactions, resulting in an enhanced understanding of local flora.

•Engaged in practical laboratory work in Zoology and Chemistry, developing skills in experimental techniques and analysis, contributing to research projects on animal behavior and chemical properties.

PROFESSIONAL EXPERIENCE

Quality Control Intern Nov 2018 – Apr 2019

Laurus Labs, Unit III, Visakhapatnam

•Conducted quality control testing on pharmaceutical products to ensure compliance with company standards and regulatory requirements.

•Developed how to develop and implement quality control protocols and testing methodologies.

•Collected and analyzed data to identify trends and ensure product consistency across batches.

•Collaborated with senior team members to troubleshoot and resolve issues in the quality control process.

Neuland Labs, Hyderabad, India Feb 2020 – Nov 2021

Research Chemist, Analytical Research and Development

Summary: Enhanced analytical specificity for complex biotherapeutics and improved lab efficiency through advanced techniques.

•Enhanced analytical specificity for complex biotherapeutics through advanced sample preparation techniques.

•Reduced data reporting times by 30% by streamlining data review processes with MS Excel macros.

•Minimized downtime and maintenance costs by 15% through troubleshooting analytical equipment.

•Authored 10 SOPs aligned with FDA cGMPs, boosting lab efficiency and compliance.

Laurus Labs Limited, Hyderabad, India Dec 2021 – Oct 2022

Associate-2, Analytical Research and Development

Summary: Conducted analytical methods and instrument calibration, contributing to product launches.

•Conducted UV-Vis spectroscopy to quantify active pharmaceutical ingredients in multi-component products.

•Validated new analytical methods as per USP guidelines, contributing to the successful launch of four products.

•Managed instrument calibration schedules, ensuring optimal accuracy across all analytical equipment.

•Improved analytical accuracy by 25% through optimized methods in UV Spectroscopy.

PROJECTS

Peptide Project, Neuland Labs, Hyderabad, India 2020

Summary: Led peptide synthesis with a focus on safety protocols.

•Led peptide synthesis on resin, emphasizing safety protocols during Fmoc decoupling using piperidine.

•Spearheaded safety initiatives to protect the team from carcinogenic piperidine exposure.

2-Deoxy-D-Glucose (2DH) Project, Neuland Labs, Hyderabad, India 2021

Summary: Addressed optical rotation issues to improve product stability.

•Addressed Specific Optical Rotation (SOR) issues to ensure product stability post-solubility.

•Stabilized 2DH solution, improving product quality for testing.

Zilpaterol Project, Laurus Labs, Hyderabad, India 2022

Summary: Conducted heavy metal tests to enhance product quality

•Conducted heavy metal tests that exposed inorganic content issues.

•Developed a leaching process to eliminate inorganic contaminants, enhancing product quality.

Oncology Project, Laurus Labs, Hyderabad, India 2022

Summary: I evaluated drug formulations' stability, including hygroscopicity and solubility studies, to enhance bioavailability and improve oncology treatment efficacy.

•Conducted stability studies on oncology drug formulations, focusing on hygroscopicity and solubility.

•Analyzed physicochemical properties to optimize stability and bioavailability.

Certifications

Occupational Safety and Health: Hazard Communication, LinkedIn Learning

Six Sigma - Green Belt, LinkedIn Learning

SKILLS

cGMP Compliance & Manufacturing, Lean Manufacturing & Six Sigma, Safety Compliance (OSHA, FDA, EMA), Team Leadership & Employee Development, Batch Record Documentation & Revision, Raw Material Management & Inventory Control, Equipment Staging & Waste Disposal, Customer Audits & Client Interfacing, Microsoft Office Proficiency, Process Improvement & Root Cause Analysis, Technical Knowledge in HPLC, UV Spectroscopy, FTIR, Wet Chemistry, Metrohm Autotitrator, SOR Analysis, Lean Manufacturing & Six Sigma

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