Quality Assurance Medical Device

EDUCATION

Northeastern University, Boston, MA, USA

APRIL 2012

Master of Science (M.S) in Regulatory Affairs for Drugs, Biologics and

Medical Devices

Relevant coursework:

New Drug Development, Medical Device Development, Managing International

Clinical Trials, Human Experimentation: Methodological Issues Fundamental

to Clinical Trials, European Union Compliance Process and Regulatory

Affairs, Practical Aspects of Regulatory Compliance

University of Mumbai - Saraswathi Vidya Bhawans College of Pharmacy,

Mumbai, India MAY 2010

Bachelor of Pharmaceutical Sciences

Relevant coursework: Forensic Pharmacy and Drug Regulations, Hospital

Pharmacy, Pharmaceutical Management, Pharmaceutics and Drug Delivery,

Pharmacology, Bio-pharmaceutics and Pharmacokinetics, Medicinal Chemistry,

Pharmaceutical Analysis, Biochemistry, Biotechnology, Dispensing Pharmacy,

Pharmaceutical Analysis Laboratory course and Human Anatomy and Physiology

WORK EXPERIENCE

Production and Quality Assurance Intern: Pfizer India LTD, Navi Mumbai,

India June 2009- July 2009

. Assisted in the manufacture of liquid orals, tablets, capsules and

surgical powders

. Performed quality control analysis such as hardness, drug content

analysis, disintegration and dissolution on tablets, capsules and

Active Pharmaceutical Ingredients

. Prepared batch manufacturing records and assisted in reviewing

Standard Operating Procedures

. Analyzed drug content in tablets, capsules and liquid oral

preparations using HPLC and UV spectrophotometer

. Assisted with sampling, warehousing, dispensing of raw materials used

in formulation

SKILLS

Regulatory Affairs Proficiency:

. Knowledge of FDA and IRB regulations, ICH guidelines, ISO 9001 and ISO

13485 quality standards; knowledge of FDA regulations for IND, NDA,

ANDA, 510(k), IDE, PMA process, HDE, PMA and 510(k) supplements;

Quality Management System and Compliance, Design Controls, GCP, GLP,

GMP standards, Labeling and Advertisement Regulations

. EU healthcare product regulatory environment and EU directives, the

organizations involved, basic understanding of the clinical trial

processes involved in the commercialization of healthcare products in

the EU, Development and Approval process for Medicinal Products and

Medical Devices(CE marking) in the EU, Regulatory Strategy for

Approval and Compliance in the EU

. Knowledge of clinical protocol development, Informed consent process,

Regulations governing clinical trials and documentation of results,

Ethical issues involved in clinical trials, Preparing for and managing

clinical studies on a global scale, Approval timelines and procedures

for conducting clinical trials in Asia, Latin America, Europe

. Post marketing surveillance, CAPA, OOS, Auditing, Risk Management

Computer skills:

. Complete knowledge of MS Word processing, MS Excel spreadsheet, MS

PowerPoint, Adobe Acrobat, Microsoft Outlook and windows operating

system

ACADEMIC PROJECTS

. Regulatory Development Plan: Worked on a project to develop a

regulatory plan for a combination product comprising of a special IV

device filled with an anti-inflammatory drug and Monoclonal antibody

for treatment of advanced stage lung cancer

June2011

. Manufacturing Exercise: Participated in a GMP compliant manufacturing

exercise under simulated conditions in a classroom and also drafted a

Batch Manufacturing Record for the exercise May 2011

. Phase III Clinical Trials: Presented a project which describes the

general plan, project goals, site feasibility studies for Phase III

clinical trials on a global scale March 2011

. Fictional IND: Drafted a Regulatory Development Plan for a fictional

drug, Request for Special Protocol Assessment for Carcinogenicity

Study and A Pre-IND Meeting Request March 2011

. Drafted a response to FDA warning letter

October 2010

. Size Exclusion Chromatography: Presented a paper on chromatographic

separation techniques concentrating on Size Exclusion Chromatography

February 2009

ACHIEVEMENTS

. Recipient of International Students Scholarship at Northeastern

University for Regulatory Affairs Program

. Served as the Sports Secretary in the Academic Year 2008-2009, and the

sports representative in Academic Year 2009-2010

PROFESSIONAL MEMBERSHIP

. Regulatory Affairs Professional Society (RAPS) student member

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