Project Manager Quality Control

NIKITA PATEL

*** ****** **, ****** ****, NJ – ***07

Cell: 606-***-**** Email: **********@*****.***

Summary:

Service minded quality control chemist analyzed routine analytical testing of generic pharmaceutical finished products, drugs in assay, related substances, and dissolution testing for release into commerce and stability samples of marketed pharmaceutical products. Meticulously detailed oriented and organized with expertize in analysis, inspections, and equipment functionality.

Skills:

Cleaning Validation (Method development and protocol execution/preparation) CIP/SIP, swabbing, sampling, setting ARL, TOC analyzer, Computer System Validation (CSV), Equipment Qualifications, Clean/Aseptic guidelines, code of Federal regulations (21 CFR), API, Ability to operate independently.

DOE, Clinical Protocols, Clinical Development Plan (CDP), cGMP, GLP, thorough understanding of Clinical Trials, Food and drug administration, ICH guidelines.

Preparing SOPs, URS / FRS, Validation Master Plan, IQ, OQ, PQ Protocols and Summary Reports, knowledge of analytical techniques such as Distillation, Desiccator, pH meter, Potentiometry, Conductometry, Polarimetry, Crystallization, Homogenizer, Centrifugation.

Pharmaceutics: Formulation of various solid dosage forms, Liquid Dosage form, Semi solid Dosage form and Parenteral.

Instrumental Analysis: Various chromatography techniques (Paper, HPLC, FT-IR, TLC, HPTLC, GC), UV Visible Spectroscopy, Karl Fischer Titration, Centrifuge, Viscometer, Particle size analyzer, Osmolarity meter, Spectrophotometry, pH meter, Density meter, Adhesion Release Tester, Tablet Compression Machine (Sejong 45, Cadmach45), Dissolution & Disintegration Apparatus, Hardness Tester, Friability Apparatus.

Chemistry: Qualitative and quantitative analysis of organic and inorganic compounds, Synthesis of Organic compounds.

Software Skills: SQL Sever, Tableau, MS Office - Word, Excel, PowerPoint, Access.

Education:

University of Massachusetts, Lowell, MA, 2015 GPA: 3.9/4.0

Master of Science (M.S.) – Healthcare Informatics & Management

North Maharashtra University (NMU), India, 2012 GPA: 3.8/4.0

Master of Pharmacy (M Pharm)

North Maharashtra University (NMU), India, 2010 GPA: 3.8/4.0

Bachelors of Pharmacy (B Pharm)

Project undertaken during Masters of Pharmacy:

Pharmacognostical, Phytochemical and Pharmacological study of Pureria Tuberosa at Smt. S.S.Patil College of Pharmacy, Chopda. India

Professional Experience:

ADH Health Product Inc. Congers, NY Aug 2016 – till date

QC Chemist

Responsibilities:

Maintenance of lab documents according to GLP guidelines, current USP and filled up log files regularly and keep it up to date.

Performing calibration, maintenance and routine sample of analysis and analytical chemistry/wet Chemistry techniques (LOD/FT-IR/KF), such as a Chromatography techniques (HPLC/TLC), ICP-OES dissolution and drug release techniques for solid dosage forms.

Calibration PH meter of various weighing and measuring equipments.

Performing assay, dissolution, content uniformity, blend uniformity, impurity, disintegration, specific gravity and other test.

Maintenance of water system by sampling, testing, releasing along with logbook entry and documentation and record tracking.

Revising methods for raw material, SOP as per USP and cGMP requirement and filling changecontrol for them.

Preparation of method validation protocols in R & D projects, method preparation, SOP preparation.

Performing microbial testing for TAC, Yeast and Mold, E. coli, Staphylococcus aureus, Salmonella species, coliform, Enterobacteria by Direct Inoculation and plate method and vial preparation And using Bio-lumix. Autoclave QC micro equipment.

University of Massachusetts, Lowell Dec 2013 - May 2015

Research Assistant

Responsibilities:

Developing health record system application for Physicians and provider facilities in order to record patient visits information.

Gathering user requirement for developing application.

Analyzing and implementing data requirement after gathering data requirement for database application.

Assigning the work to team members and also responsible for keep track of the project.

Designed and tested SQL server database application.

Final document reviews were done which included the User Requirement and Data Requirement.

Flamingo Pharmaceutical Pvt Ltd. Mumbai, India Jan 2012 - Dec 2012

Quality Assurance Analyst

Responsibilities:

Performed various chemistry tests like pH measurement, HPLC, Gas Chromatography (GC) etc.

Responsible for adjusting formulas and preparing blend sheets for review and approval by R&D department.

Responsible for samples testing and submitting test results in requested format.

Worked with team that evaluated and provided recommendations to improve product quality of the enzymes and animal feed product.

Investigated and offered viable solutions for problem batches, leveraging analytical strengths to isolate issues and facilitate their timely resolution.

Developed and maintained an organized record keeping system and prepared meticulous lab reports.

Involved in manufacturing processes like Drying, Blending, Granulation, Compression and Packing.

Experience in handling, Monitoring and controlling instruments like Tray Dryer and Spray Dryer.

S.I. Chemical Industries, Shahada, India July 2010 - Feb 2011

Chemist

Responsibilities:

Handling of Tablet manufacturing process (Granulation, Compression and Coating Department).

Responsible for in-process quality control test on tablets such as friability test, hardness test, dissolution tests, weight variation etc.

Analysis and evaluation of Tablet formulation using HPLC, IR and UV/VIS.

Calibration of pH meter, Weighing balance, Adhesion Release tester and Probe Tack tester.

Performed chemical solution preparation, mobile phase, diluents & buffer preparation.

Evaluate, interpret and present data to project manager in accurate and reliable manner

Online completion of BMR and yield reconciliation.

Responsible for maintaining batch records.

Worked on developing SOP’s & reviewing existing SOP’s for process improvement using cGMP.

Ensure delivery of quality products as per the set schedule by R & D.

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