Summary
Overview
Work History
Education
Skills
References
Accomplishments
Languages
Websites
References
Timeline
Generic

RAJVI PATEL

Dunellen

Summary

Accomplished Senior AR&D Data Reviewer & Technical Writer at Cosette Pharmaceuticals, adept in GMP and FDA submissions, showcasing expertise in Empower software and exceptional teamwork. Proven track record in enhancing document compliance and efficiency, with a pivotal role in successful FDA inspections.

Overview

13
13
years of professional experience

Work History

Senior AR&D Data Reviewer & Technical Writer

Cosette Pharmaceuticals
South Plainfield
03.2024 - Current
  • Performs GMP technical data review of notebook to support FDA submissions such as BioEquivalence studies, method validations, cleaning methods and Product Development activities
  • Thorough understanding of GMP, Documentation, compendial requirements such as USP & EP
  • Writes SOPs, analytical reports, protocols & methods
  • Performs root cause analysis and impact statements for Quality events such as Deviations, change controls etc
  • SME of Document Change Controls using Veeva to revise controlled documents as needed to meet industry standards
  • Works with various departments’ SMEs and stake holders to address comments and routinely follows up to ensure approvals are completed to meet the targeted timelines
  • Issues & achieves original documents and notebooks
  • Conducts audit of the laboratory to maintain cGMP and works with the impacted departments to ensure observations are resolved
  • Provides guidance for GxP to maintain compliance with regulatory requirements
  • Proficient with MS Office, Adobe, Empower, Veeva, Trackwise
  • Ability to prioritize conflicting demands and executing assigned tasks within an established schedule
  • Acts as the SME of R&D for Agency Inspections due to the ability of successfully navigating FDA inspections
  • This includes providing clear and comprehensive responses to questions from the FDA inspector on a one-on-one basis and providing backroom support for all audits

AR&D Technical Writer/Reviewer

Cosette Pharmaceuticals
South Plainfield
12.2019 - 03.2024
  • Involved in writing/ Reviewing Reports, Technical Reports and SOPs related to Analytical laboratory
  • Initiating Change Controls through QUMAS and/or TrackWise for documents and procedures
  • This included updating/creating Analytical Test methods, and R&D SOPs
  • Contacting various department’s SMEs and different stake holders to address their comments, finalize the Analytical documents, and follow up for their approval process in a timely manner to meet the targeted timelines
  • Retain/Archive original documents and notebooks
  • Performed GMP technical data review and notebook for Analytical activities for method validation (MV), method transfer (MT) and testing of Analytical Product Development (PD)
  • Periodic audit of the laboratory to maintain cGMP
  • Involved in providing guidance for good documentation practices as per company’s SOP guidelines
  • Proficient with MS Office, Adobe Acrobat application, Empower software
  • Ability to prioritize conflicting demands and executing assigned tasks within established schedule

AR&D Scientist III

Ohm’s lab, a Sun Pharma Company
New Brunswick
04.2017 - 12.2019
  • Involved in the development and optimization of new and existing analytical methods for qualification of active pharmaceutical ingredients and release testing of finished products
  • Worked with Regulatory Affairs and Formulation to support a products development through submission
  • Wrote and reviewed Protocols, Analytical Procedures, Reports, SOPs, and Investigations
  • Observed trends and made management aware of OOS/OOT’s
  • Wrote investigations, including performing the root cause analysis, and developing corrective and preventive actions (CAPA)
  • Trained peers on the implementation of CAPAs to prevent recurrence of same error
  • Ensured CAPA’s and investigations were closed to meet timelines
  • Designed protocol studies and performed method validation of test procedures such as Assay, Dissolutions, Related Substances and Cleaning Verification using HPLC
  • Prepared reports for analytical method development, multimedia dissolution reports, method validation and vendor qualification reports
  • Worked to troubleshoot instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FT-IR), Ultraviolet-visible (UV-Vis) spectrometers, Karl-Fischer titrator (KF titrator) and Dissolution apparatus on a daily basis
  • Hands on experience for testing Method Validation Parameters- Specificity, Linearity, Accuracy, Method Precision, establishing analytical solutions stability, Robustness, Forced Degradation studies, Intermediate Precisions
  • Completed documentation, processing of results generated using empower, calculations and compilation of results
  • Tested in-process, finished products and blend samples for test such as Dissolutions, Assay, Related Compounds, Content Uniformity, Blend Uniformity, KF of R&D and scale up batches
  • Trained new hires on the current GMP procedures and techniques

Scientist (Temp)

Catalent Pharma Solutions
Somerset
10.2016 - 01.2017
  • Operating & Trouble shooting of- HPLC, UPLC, UV-Vis, FTIR, Volumetric KF
  • Performed Dissolutions, Assay, Related Compounds (Impurities), Purity, Blend Uniformity, Content Uniformity, Moisture content and ID tests
  • Processed and documented data collected using TotalChrom
  • Monitored results for trends and investigated OOS results

Analytical Chemist

Alcami Corporations (FKACambridge Major Laboratories, Inc.)
Germantown
08.2014 - 09.2016
  • Operating & Trouble shooting of- HPLC, UPLC – Both Waters and Agilent (Software : Empower 3 & Chem Station/Open lab), TGA, GC (Chem Station), Volumetric KF, Coulometric KF, Auto-titrator (LabX software), IC (chromeleon software), Malvern Particle size Analyzer
  • Performed tests like Purity, Impurity, reaction Completion, Assay testing, Appearance, IR, Water contents, Sodium and Chloride content test, Method transfer and Intermediate Precision of Finished and In-process API products and Raw materials
  • Strict Adherence to cGMP environment
  • Developed a thorough knowledge of GMP and GLP
  • Performed analytical testing on in-process products, finished products, stability products and raw materials to ensure adherence to product specifications
  • Maintained daily Lab records- including Notebook write ups, logs for equipment’s usage and forms
  • Lead basic training for writing Deviations and updating test methods
  • Reviewed daily testing and reported results to Production/Manufacturing to support the ongoing processes of API manufacturing reactions
  • Worked with scheduling to ensure support for tasks at required times
  • Training Team Member- included preparing training modules and training peers

AR&D Scientist-II

Amneal Pharmaceuticals
Brookhaven
06.2012 - 07.2014
  • Perform stability study of New Drug Products and Generic Formulations
  • Operating & Trouble shooting of- HPLC, UPLC – Waters (Software : Empower-2 and Empower3), UV-VIS
  • Operated instruments such as KF, PH meter, FT-IR, Dissolution (Sotax & Distek)- Type: (I) Basket, (II) Paddle & (IV) Flow through Cell, Disintegration apparatus, High speed Homogenizer, Ultrasonicator, Ultra centrifuge, and Hardness tester, Tap and Bulk density tester
  • Performed tests such as Purity, Impurity and Assay testing of Finished Oral solids, Dissolution, Assay, Related Compound, Content Uniformity, Blend Uniformity, Antioxidant content, Water content testing of Finished Products (Oral solids) and Appearance, IR, LOD, ROI, Heavy metal testing of Raw Materials
  • Daily calibration of Analytical Balance, pH meter and Karl-Fisher Apparatus
  • Daily reading/monitoring of charts for stability chambers and replacing with new chart weekly

Education

Master of Science - Industrial Pharmacy

Long Island University
Brooklyn, New York, USA
05.2012

Bachelor of Science - Pharmaceutical Sciences

Sinhagad Collage of Pharmacy
Pune, Maharashtra, India
05.2010

Skills

  • Master’s Degree
  • GMP
  • ANDA
  • Drug Master File
  • 21 CFR/USP/EP
  • ICH Guidelines
  • FDA guidance
  • Empower software
  • Chem Station software
  • Total Chrom Software
  • MS Office
  • Adobe
  • Trackwise
  • Veeva
  • SOPs
  • Time Management
  • Multitasking
  • Verbal, Written and Presentation Skills
  • Training Peers
  • Report writing
  • Teamwork and collaboration

References

Available upon request.

Accomplishments

  • Rho Chi award at LIU

Languages

English
Native/ Bilingual
Hindi
Native/ Bilingual
Gujarati
Native/ Bilingual

References

References available upon request.

Timeline

Senior AR&D Data Reviewer & Technical Writer

Cosette Pharmaceuticals
03.2024 - Current

AR&D Technical Writer/Reviewer

Cosette Pharmaceuticals
12.2019 - 03.2024

AR&D Scientist III

Ohm’s lab, a Sun Pharma Company
04.2017 - 12.2019

Scientist (Temp)

Catalent Pharma Solutions
10.2016 - 01.2017

Analytical Chemist

Alcami Corporations (FKACambridge Major Laboratories, Inc.)
08.2014 - 09.2016

AR&D Scientist-II

Amneal Pharmaceuticals
06.2012 - 07.2014

Master of Science - Industrial Pharmacy

Long Island University

Bachelor of Science - Pharmaceutical Sciences

Sinhagad Collage of Pharmacy

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