Pavitra Bhatt

Piscataway

Summary

Skilled Chemist with extensive experience in analysis, laboratory practices, and quality control testing for multinational pharmaceutical company. Demonstrated skills in regulatory inspection, good manufacturing practices and technical writing. Excellent theoretical and practical knowledge and experience in HPLC, UV-VIS, IR analysis and Dissolution techniques. Proven ability to manage multiple responsibilities in a fast-paced environment with critical deadlines. Able to work independently as well as collaboratively in a team setting.

Overview

years of professional experience

Work History

QC Chemist

Biocon Generics Inc

Cranbury

04.2026 - Current

Conducted quality control tests on raw materials and finished products.
Performed chemical and physical analyses of raw materials, in-process samples, and finished products to ensure quality control standards are met.
Analyzed chemical compositions using advanced laboratory equipment.
Analyzed samples submitted for testing and reported results.
Developed and maintained standard operating procedures for testing processes.
Ensured compliance with regulatory standards and industry guidelines.
Collaborated with cross-functional teams to resolve quality issues.
Calibrated lab instruments regularly according to manufacturer's instructions.
Prepared test solutions, compounds and reagents for laboratory tests.
Ensured all chemicals used in laboratory analysis were stored safely according to safety protocols.
Evaluated test results for accuracy and completeness prior to release of product or materials.
Reported any issues or discrepancies found during testing activities to the Quality Manager promptly.
Managed inventory of supplies required for laboratory operations such as glassware, reagents.

Senior Chemist & Data reviewer

APP CO PHARMACEUTICAL LLC

Somerset

09.2017 - 01.2020

Test raw materials, in-process samples, finished products, stability samples, complaint samples, protocol samples, and process validation samples by in-house and USP/NF methods in accordance with cGMP.
Tests solid dosage form samples for Assay, Content Uniformity. Perform Blend Uniformity and Final-- Mix assay as per established guidelines like QCMS and SOPs by HPLC.
Perform Tablets and Capsules Dissolution Single point and Profiles by (UV-VIS) and by HPLC.
Conduct Identification by HPLC Assay.
Perform testing of Cleaning Verification by HPLC and UV Spectrophotometry.
Perform water determination by Karl Fisher titration.
Collaborated cross-functionally with Metrology, production, and Research & Development to resolve instrument, sample, and testing issues.
Delegated tasks, mentored chemists, and reviewed their performance to enhance team capabilities.
Calibrated and maintained laboratory equipment, ensuring compliance with cGMP standards.

Chemist-A

AUROLIFE PHARMACEUTICAL LLC

Dayton

06.2017 - 09.2017

Perform testing on raw material, In- Process, Finished Product, Stability, Complaint Sample, Protocol Samples and process validation samples by In-house and USP/NF methods in accordance with cGMP which required a working knowledge of the chemistry and instrumentation involved.
Perform Tablets and Capsules Dissolution Single point and Profiles by (UV-VIS) and by HPLC.
Conduct Identification by HPLC, IR, and Assay.
Tests solid dosage form samples for Assay, Content Uniformity, and Blend Uniformity.
Generates linearity data and Dissolution profile results.

QC Analyst & Data Reviewer

IMPAX LABORATORIES/CORE PHARMA

Middlesex

01.2006 - 04.2017

Test, analyze and report on development of new generic solid dosage, capsule and coated tablets from laboratory scale to commercial. Collaborate with cross-functional teams to execute change controls associated with manufacturing and packaging master records SOP, protocols. Perform routine daily standardization on laboratory equipment, ensured compliance with cGMP and participated in troubleshooting and problem solving.
Communicate cross functionally with Metrology, production and Research & Development for instrument, sample and testing issues.
Delegate, mentor and review the performance of chemist. HPC, TLC,GC, Spectrophotometry, Dissolution testing ,Wet Chemistry , R&D
Perform testing on raw material, In- Process, Finished Product, Stability, Complaint Sample, Protocol Samples and process validation samples by In-house and USP/NF methods in accordance with cGMP which required a working knowledge of the chemistry and instrumentation involved.
Perform Tablets and Capsules Dissolution Single point and Profiles by (UV-VIS) and by HPLC.
Conduct Identification by HPLC, IR, and Assay.
Tests solid dosage form samples for Assay, Content Uniformity.
Generates linearity data and Dissolution profile results.
Perform water determination by Karl Fisher titration.
Calibrates and maintains laboratory equipment, ensure compliance with cGMP.
Assists other chemists in analyzing, calibrating and troubleshooting laboratory instrumentation.
Perform as backup personnel for Controlled Substance Coordinator.
Maintain the Laboratory chemical inventory and column Inventory.
Complete work with timeframe for in-process, finished product, stability sample release and report data to supervisor.

Education

Bachelor of Science (BSC) - Chemistry

Gujarat University

Gujarat, India

Skills

Laboratory: Quality Control, R&D
Analysis: Method Transfer, Process Validation
Testing: Finish Product, Stability, In-process, Raw material, Complaint Sample

Regulatory & Compliance: FDA regulations, ICH Guidelines, and OSHA requirements
Computer: LIMS, Empower, Totalchrom data acquisition software, Microsoft Office (Word, Excel, Publisher, and PPT)

Timeline