BHAUMIK PATEL

*** ******** *** ***** ***, Harrison NJ-07029 Cell: 973-***-**** E-Mail: ac0gmp@r.postjobfree.com

CAREER OBJECTIVE

To implement my resourceful knowledge and analytical skills of Pharmaceutical Sciences and to work safely and ethically in Pharmaceutical industry for the benefits of the organization and mankind.

EDUCATIONAL CREDENTIALS

Maters in Chemistry (Pharmaceutical Chemistry –main concentration) 2015

Fairleigh Dickinson University, Metropolitan Campus, Teaneck, NJ

Masters in Pharmaceutical Quality Assurance 2013

Gujarat Technological University, Gujarat, India

Bachelors in Pharmacy 2011

Maharaja Krishnakumarsinhji Bhavnagar University, Gujarat, India

PHARMACEUTICAL INDUSTRY PROFESSIONAL:

Scientist 1

Amneal Pharmaceuticals, Piscataway, NJ May 2016 - Present

Hands on Performing Dissolution analysis of Pre-formulation samples.

Hands on operation and interpretation of Analytical instruments like HPLC, UV- Visible Spectrophotometer, Dissolution Apparatus.

Carried out the analysis of pharmaceuticals products for its quality using modern analytical techniques and instruments like, High Performance Liquid Chromatography, UV -Vis Spectrophotometer, Dissolution Apparatus (USP Apparatus 1& 2), etc. for test of Assay, Dissolution using current IP, USP and in-house test methods.

Assisted Senior Scientist in Method development and validation of an analytical method for Assay. Assisted in performing metal detector instrument ICP.

Excellent communication skills.

Experienced working in cGMP compliant lab.

Performed calibration, qualification and maintenance of laboratory instruments.

Hands on basic instruments needed for analysis of raw material/solid dosageform/semi-solid dosage form such as KF titration, Rheometer, Polarimeter, Conductometer, Refractometer, FT-IR, Sieve analysis, Microscopy, Malvern etcetera.

Worked on solid dosage forms, semi-solid dosage forms, liquid dosage forms, transdermal patch.

QA Officer 1 Jan 2013 – November 2013

Dial Pharmaceuticals, Ahmmedabad, India and Molecule laboratory, India

Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations

Knowledge of US and ICH safety reporting regulations and guidelines with basic understanding of FDA regulations.

Knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements, and guidelines

Knowledge of Working with cross-functional departments and developing standard operating procedures

Applied "fit for purpose" and "Right first time" principles of quality assurance inspection.

Read and interpreted blueprints engineering documents and product specifications.

Knowledge of how to Write and review relevant Standard Operating Procedures (SOPs) and preparing, executing and finalizing equipment, system and utility IQ, OQ and PQ’s.

Theoretical knowledge on how to Perform validation studies, evaluates and analyzes validation data related to projects and Maintaining compliance of Manufacturing/Quality Control/Development equipment through the requalification

Implemented a quality assurance system. Hands on line clearance and batch manufacturing record.

Randomly selected products prior to packaging for quality testing.

PROJECTS UNDERTAKEN

Bachelors Project

-Validate process and calibrate instruments while working under production department in tablet and capsule filling machine in Dial Pharmaceuticals Pvt. Ltd

Research Intern (Oct 2010 to June-2011) in Tablet and Capsule section at Dial Pharmaceutical Pvt. Ltd, Gujarat, India

Masters Project

- Thesis carried out on method development and validation for estimation of Enalapril maleate and Losartan potassium in pharmaceutical dosage form using RP-HPLC and stability study.

Research Intern (Oct 2012 to April 2013) working on RP-HPLC at Molecule Laboratory, Gujarat, India.

Areas Of Interest

Analytical R & D

RECOGNITIONS EARNED

Formulation

Pharmacovigilance & Regulatory Affairs

Research paper published in Indo American Journal of Pharm Research.2013:3(5).PP-3767-3790.

Completed computer course CCC from DOEACC society.

References: Available on request

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