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Quality Control Medical Device

Jersey City, NJ, 07306
40000 to 50000usd
August 13, 2012

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Sneha Amin

***, ****** ******, *** **, Jersey city, NJ 07306


Objective: Exploring full time career opportunities in the Pharmaceutical, Biochemical or Medical Device Industry in a challenging dynamic work environment to make a strong contribution by utilizing and expanding upon related education, skills, experiences and capabilities.

Education; Master of Science in Drug Regulatory Affairs May 2012

Long Island University, Brooklyn, NY

Bachelor of Pharmacy Oct 2008

K.L.E College of Pharmacy, Hubli, India

Major Subjects: GMPs in Pharmaceutical Facility Design, Validation & Regulatory Affairs, Design and Management of Aseptic Pharmaceutical facility, Pharmaceutical Finishing & Packaging, Quality in Pharmaceutical Manufacturing, Regulation & Compliance in Pharmaceutical industry, Project Management, Engineering Economics and Cost Analysis.

Academic work; Long Island University, Brooklyn

• Presented a webinar on Regulatory Certification Program (RCP) for DRA Solutions. This presentation is used as a template by the Marketing department of the company for RCP presentations worldwide.

• Review and compiling of documents for preparation of Investigational New Drug Application (IND), Abbreviated New Drug Application (ANDA) and Biologics License Application (BLA).

• Review and compiling of documents required for registration of new product in USA, Europe and Canada.

• Preparation and review of documents required for the registration of drugs in India (CDSCO), and Europe (EMEA).

• Preparation and submission of 510(k)


Pharmacist Trainee; January-Nov2009

Acutest Research Laboratory.

• Tablet, capsules & liquid oral section

• Planning, packaging, storage & testing of pharmaceutical raw materials and different formulations.

• Handling of machinery,equipment and modern instrument

• Record keeping &personal management.

• Investigate deviations and take corrective action to resolve the deviations.

• Sampling and performing Quality control Tests on Finished drug product.

• Documentation of the test results and getting it approved by the Quality Control Head.

Volunteer as a Companion

Maimonides Medical Center.

• Assist with office duties such as filing, copying, performing computer Data, answering phones, managing patient confidential files with documentation work, preparing the report, etc.

• Provide companionship to lonely and anxious patients, escort patients and visitors to and from various areas within the Medical Center, assist staff with meal distribution, perform errands and deliver messages.

• Supported in taking medication history from the patients and give proper guidance in taking medication on scheduled time.

• Gathered information on patient file.


Laboratory Skill : High-Performance Liquid Chromatography (HPLC), CIP Process with Total Organic Carbon (TOC) Analysis, UV Spectrometer, Dissolution & Disintegration Apparatus Generate SOP based on cGMPs and Design of Experiment (DOE), FMEA

Computer Proficiency: Microsoft Office (Word, Excel, Access, PowerPoint)

Interpersonal Skill: Team Dynamics, Strong communications skills, multitasking

Quality Skills: 21 CFR Part 11, 21 CFR Part 210 &211, 21 CFR Part 820

Software skills: SAS, SPSS


• Represented as Ladies Representative of entire college, 2007

• Represented as Ex-officio Member of Pharmacy College, 2008 and held responsibilities with full of dedication and determinations.

• Provided clerical support to the faculty of college and snapped with the Dean and Faculty in the front page of the college book, which gets launched every 3 year

• Served as a Volunteer to raise funds for Help Age India, NGO and served needy people.

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