Quality Control Management System

Neel Shah

*** ******* ***,

Jersey City, NJ-*7306

Email: ******@*****.**.**

Contact: 201-***-****

OBJECTIVE:

Aspiring for a position in a pharmaceutical company which will give me the opportunity to learn and apply scientific

techniques in Research and development, Formulations and Analytical department

EDUCATION:

Long Island University, Brooklyn, NY Dec’10

Master of Science in Pharmaceutics,

Major: Industrial and Physical Pharmacy

Rajiv Gandhi University of Heath Science, Bangalore, India Oct ‘07

M.S. Ramaiah College of Pharmacy

Bachelor of Pharmacy.

Catalyst Clinical Services Limited, Delhi, India May ‘07

Post graduate diploma in clinical research (PDCR)

SUMMARY

• Experience working in Laboratory environment following cGMP regulations.

• Expert in verifying chemical integrity and chemical composition of products.

• Demonstrated strong industry experience utilizing HPLC, GC, UV visible spectroscopy, Fourier Transform IR

(FTIR), Basket and Paddle type Dissolution apparatus.

• Can effectively troubleshoot and solve instrument and analytical method problems on above instruments.

• Familiar with FDA regulations, cGMP and other ICH guidelines.

• Excellent written, oral and organization skills.

• Profound experience in writing, reviewing and revising SOPs

• Good experience in gathering the test data, analyzing the data using statistical tools and reporting the data following

Good Document practices

• Computer skills: MS-Word, MS-Excel, MS-PowerPoint. MS-Access.

• Experience using Microsoft Office software and LIMS.

• In depth knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP)

EXPERIENCE:

Amneal Pharmaceuticals, Feb’11 - Current

Hauppauge, NY, USA .

Scientist-1

Responsibilities included

• Performing disintegration and dissolution testing on solid dosage forms.

• Writing, reviewing and revising SOPs/Test Protocols/Methods of Analysis.

• Performing sample preparation procedures using a number of techniques such as extraction, sonication, solvent

evaporation, dilution, and filtration.

• Analyze samples obtained from various sources using SOPs to demonstrate compliance with the relevant

specifications on HPLC, GC, UV/VIS-Spectrophotometer, Karl Fischer Moisture Meter, pH Meters, Wet

Chemistry Techniques.

• Calibrate and maintain laboratory equipment such as pH meters, Auto titrators, Weighing balances in accordance with

manufacturer recommendations

• Troubleshoot and solve problems encountered with methods and instrumentation.

• Assist supervisors with document revisions.

• Maintaining neat, accurate, and complete laboratory records required for an FDA audit.

• Perform algebraic calculations to quantify test results.

• Performing other lab-related duties or tests as assigned by the immediate supervisor.

• Report final test results in the computerized Laboratory Information Management System (LIMS).

Neel Nayan Pharma Pvt. Ltd. (India) Oct’07 – Aug’08

Formulation Scientist

Responsibilities included

• Design studies related to pre-formulation and formulation of solid dosage forms, including solubility, pH solution

stability, and others that may impact the stability and delivery of the product.

• Conduct lab testing, as necessary, on lab scale batches to ensure meeting formulation requirements.

• Demonstrating formulation and process feasibility on laboratory scale.

• Developing method transfer of laboratory processes to production scale.

• Determining causes of problems in existing formulations and processes and identifies and implements enhanced

formulas for placement on stability and subsequent introduction into production.

• Writing and reviewing protocols and Batch Manufacturing Record (BMR).

• Working in accordance with all company policies and procedures.

Reine Chemicals Pvt. Ltd. (India) May’07 – June’07

Research Intern

Responsibilities included

• Rotated through various departments at bulk drug manufacturing company.

• Completed all necessary training on industry regulation and SOPs

• Wash glassware as needed and maintain a clean working environment .

• Observed operations in quality control, production and packaging of bulk drugs.

SEMINARS:

• Developed Factorial Designs and Simplex Lattice Designs optimizing Lubricant level, Mixing time and Drug

dissolution under guidance of Dr. Rutesh Dave at Long Island University.

• Presented a Seminar on “Gastro Retentive Drug Delivery System and different approach” under guidance of Dr.

Almas Babar at Long Island University.

• Presented a Seminar on “Targeted prodrug design to optimize drug delivery” under guidance of Dr.S. Bharath at M.S.

Ramaiah College of Pharmacy, India.

Reference

• References are available upon request

Contact this candidate