Medical Device Quality Assurance

Jatin Jansari

*** **** ******, (***)

*** - ****

Boston, MA 02120

*******.*@*****.***.***

SUMMARY

Acquired knowledge and have excellent abilities assisting in regulatory submissions for a Novel Drug/Medical Device

Special competencies in Good Clinical, Manufacturing and Laboratory Practices, Investigational New Drug application, Form

FDA 356h, Human Experimentations for Clinical Trials and Informed Consent, Institutional Review Board, Effective in SOP

writing, Investigational Device Exemption, Quality System Regulations, Code of Federal Regulations

EDUCATION

Northeastern University

Boston, MA

Master of Science, Regulatory Affairs for Drugs, Biologics and Medical Devices (GPA: 3.3) Exp. June

2013

Relevant Coursework: Introduction to Drug and Medical Device Regulations, Human Experimentation: Methodological Issues

fundamental to clinical trials, Advanced Writing on International Biomedical Topics, A QA/Regulatory overview of New Drug, Biologics

and Medical Device Development, European Union Compliance Process and Regulatory Affairs, Food, Drug and Medical Device Law

Gujarat University

Ahmedabad, India

Bachelor of Pharmacy

June 2011

Relevant Coursework: Clinical Pharmacy, Pharmacology, Industrial Pharmacy, Medical Chemistry, Analytical Chemistry

WORK EXPERIENCE

Planet Health, GPSAR Healthcare Ltd. (www.planethealth.in) Ahmedabad,

India

Pharmacist May –

October 2011

Advised patients on proper dosage in order to maintain customer satisfaction levels and patient compliance

Performed patient-counseling, examined medical prescriptions and dispensed the medicines confidentially and in obligatory manner

Conferred with doctors on special occasions to resolve various prescription discrepancies for the ease and aid of patients

Maintained and documented patients’ sickness and medication data, reviewed and updated it on regular intervals for the

changes in the medication and/or dosage and patient conditions

West-Coast Pharmaceutical Works Ltd. (www.westcoastin.com) Ahmedabad,

India

Intern – Quality Assurance July 2010 –

January 2011

Reviewed documents and created Quality Operating Procedures, Risk Analysis Reports, Inspection Records and associated

records

Assisted the manager to accomplish the internal quality audit and developed the audit reports and CAPA reports.

Developed and went over the sterile facility parameter reports, annual product quality reports (APQR) and statistical data

while working as a cGMP coordinator

Surveilled site of production on regular bases and reported contamination and packaging deficiencies to ensure persistent product

quality

Performed Quality Control testing for tablets such as friability test, disintegration test, dissolution test, weight uniformity. Tablet

thickness and hardness test and carried out finished product packaging and labeling as per the required regulations

Corresponded the manufacturing manager on regular intervals for batch variations and issues resulting from recorded reviews,

internal audits of facility and deviation issues and resolve any quality concerns of the final product

ACADAMIC PROJECTS AND ACHIEVENTS

Wrote a review article on “Application of Biopharmaceutics Classification System in Formulation Development” which was

published in Indian Journal of Pharmaceutics, Rajasthan, India (www.ispjournals.com)

Northeastern University:

• New Drug Application submission: Corresponded as a company statistician and exhibited solid statistical data for our product

in a group presentation exercise as per 21 CFR 314

• Pre – IND meeting: Part of the pre-Investigational new drug meeting executed as a class exercise as per 21 CFR 312.82(a)

and represented as a of lead of the quality-assurance department for the FDA submission in group exercise and worked

collaboratively with other teammates to pose strong grounds for approval of IND submission

• SOP: Prepared scrutinized Standard Operating Procedures under the Good Laboratory Practice part of 21 CFR (21 CFR

58.81)

• 510(k) submission and EU submission: part of the class practice for the traditional, special and abbreviated 510(k)

submission and fictitious class IIb medical device regulatory strategy development process for US and EU resp.

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