Quality Assurance Control

Priyank RajeshKumar Shah

** ******* ****, **** # **, Boston, MA 02115 617-***-**** acesvr@r.postjobfree.com

EDUCATION

Northeastern University, Boston, MA

College of Professional Studies May 2015

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices GPA: 3.834 / 4.00

Relevant Courses: Introduction to Drug and Medical Device Regulation, Human Experimentation:

Methodological Issues Fundamental to Clinical Trials, Medical Device Development and New Drug

Development, Biologics Development: A QA/Regulatory Overview and European Union Compliance Process and

Regulatory Affairs.

Completed 10 graduate level courses towards MS in Pharmaceutics & Drug Delivery earning a GPA of 3.75.

University of Mumbai, Maharashtra, India May 2012

Bachelor of Pharmacy, Distinction GPA: 3.92 / 4.00

Licensed Pharmacist in India

SKILLS

Regulatory: Familiar with 510 K Submissions, IND, PMA, BLA, NDA, Global Regulatory Affairs, FDA, 21

CFR, IDE, Clinical Trials, GMP, GCP, GLP, CAPA, ICH Guidelines, Quality Assurance and Quality Control,

CMC, PDUFA, Post-market Surveillance, IVD, Regulation of Combination Products and Labeling.

Technical: Familiar with ELISA, Western Blot, HPLC, Gel Electrophoresis, BCA Assay, UV-Vis Spectroscopy,

Mammalian Cell Transfection Techniques, Nanoparticle formulation, Cytotoxicity Assay

Personal: Effective Communicator, Analytical & Problem Solving Skills, Keen Observer & Attentive Listener,

Team Player

Computer: Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Access, AutoCAD and HTML

PROFESSIONAL AND RESEARCH EXPERIENCE

Center for Pharmaceutical Biotechnology & Nanomedicine Jan 2013 –

Jan 2014

Dr. Vladmir P. Torchilin’s Lab, Northeastern University

Research Assistant

• Focus on Formulation and Characterization of Liposomal Drug Carriers; Compile and report on

data

• Prepared lab reports, presented results, compiled data on QA, QC and reviewed regulatory

documents

Bombay Hospital, India May - June

2011

Summer Intern

• Formulated and dispensed various prescription drugs; maintained hospital inventory

• Aided in Documentation and Archiving of the drug inventory as per Indian regulatory laws

• Assisted in regulatory submission of medical devices (510K) and reporting of adverse drug reactions in

the hospital patients

Khandelwal Labs Pvt Ltd., India Nov - Dec

2011

Research Intern

• Studied formulation techniques for a variety of anti-cancer drugs and their delivery

• Oversaw the labeling process and drafted the protocols and manufacturing records

• Assisted in writing QC testing protocols and report. Documented findings in Quality Control and

Quality Assurance departments and reviewed regulatory documents

ACTIVITIES

• Secured Second Place for poster presentation on “Plastic Antibodies” at IPA-SC 2010 conducted by IPA

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