Data Entry Medical Device

Ms. NIYATI SHAH

***, *** ***** ****, ******, MA *2215 +1-973-***-****) **************@*****.***

EDUCATION

Northeastern University, Boston Sep 2015

GPA 3.5

Master of Science in Regulatory affairs for Drugs, Biologics and Medical Devices

Courses: Drug and Medical Device Regulation, International writing on Biomedical topic, New Drug development: Regulatory overview, Medical Device development: Regulatory overview, Biologics development: Regulatory overview, Emerging trends in Medical Device development

Ramanbhai Patel College of Pharmacy, CHANGA University, Ahmedabad, India May 2014

GPA 3.4

Bachelor of Pharmacy: Theoretical and practical Knowledge in Pharmaceutical and Medicinal chemistry (Laboratory Work), Biotechnology, Microbiology, Biochemistry, Herbal drug technology, Pharmacognosy, Clinical pharmacology, Biochemistry, stereochemistry, Entrepreneurship Management, Jurisprudence, Hospital pharmacy, Biostatistics and biostatical analysis, Humana pathophysiology and clinical pharmacy, Documentation

TECHNICAL SKILLS

Regulatory Skills: SOP preparation and submission, BLA, AND, ANDA, IND, 21 CFR 820, CFR 600-660, Orphan drugs, QSR (Quality System Regulation), PMA, PMA supplements, Design control, Pre-market notification{(510(k)}, ICH guidelines, Packaging and labelling requirements, Informed consent, IRB requirements, Regulatory knowledge of FDA, FDASIA, FDAMA, FDAAA

Quality: GLP, GMP, GCP, ICH guidelines, 21 CFR part 300, 21 CFR part 800

Software skills: Prominent knowledge of Microsoft office related program such as MS word, Excel, PowerPoint, Access, Brief knowledge of Outlook, One Note, C language, sound knowledge of Adobe Acrobat, Data entry, Data analysis

EXPERIENCE

TRAINING

Industrial Internship Program at INTAS Pharmaceuticals Ltd., Ahmedabad, India May 2013 Manufacturing Unit and Production Unit

Packaging and Labelling

Batch record review

SOPs review of medicinal products, drug at very brief

Standard operating procedure for different unit of manufacturing devices at laboratory level such as tray dryer, hot air oven, ball mill.

Industrial Training program at INTAS Pharmaceutical Ltd., Ahmedabad, India June 2014

Quality Control and Quality assurance in brief

Reviewed and observed standard operating procedure(SOP)

Acquired brief knowledge of GMP and GLP

Volunteer Experience in Pharmacy Store, Ahmedabad, India January-Feb 2015

Manual Data Entry and knowledge of OTC drugs as well as prescription drugs

Deal with patient counselling and consultation

Brief knowledge over Medication safety

Hospitality and Guest Management, Changa, India Feb 2014

Team member of AVALANCHE’14 event during curriculum. Achieved a certification for excellent performance skill of hospitality and guest management.

Managed event duties that include planning of an entire AVALANCHE event, food service and guest welcoming session, recreational activities

Regulatory brief overview

Documentation

SOPs review and maintenance

Have come across different guidelines that are needed for drug development

Process on how marketing evaluation and post marketing surveillance carried out

ACADEMIC PROJECTS

Analyzed and prepared an international biomedical topic on PSORIASIS-ALLOPATHIC VS. AYURVEDIC MEDICINE approach.

Presented an entrepreneur presentation on KIRAN MAJUMDAR as a curriculum practice.

Organized and presented a successful pharma company set-up and resources that required to growth of a pharmaceutical company as a part of curriculum of pharmaceutical management.

Made a project on HERBAL DRUG TECHNOLOGY of “Vasaca leaves”.

Submitted assignments and projects related with 510k submission, Clinical protocol, Drug package inset, Informed consent forms, pre-IND meeting request letter

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