Quality Control Medical Device
Resume:
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)
Experience;
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.
Skills:
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
Activities:
• 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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