Quality Assurance Medical Device

Nishi Christian

**** ******* ***** ****: 719-***-****

Colorado Springs, CO 80922 abn4jw@r.postjobfree.com

Professional Overview

● Regulatory Affairs professional intending to build an eclectic career in Regulatory Affairs centered on

the preeminent academic background and professional acumen in health care industry to make

constructive contributions to the society as well as to intensify my professional advancement.

● Meticulous academic exposure to US FDA regulations, ICH, GCP, GMP, Quality Standards, Quality

Management.

● Demonstrated analytical and communication skills that comprehend recognizing critical concepts, solving

complex problems, presenting complex ideas in a clear, concise and influential manner and keen

attention to detail.

Summary of Skills

Regulatory Submission Regulatory Affairs

● ●

IND, NDA and

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eCTD and SPSS ANDA

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21 CFR and 510(k) Medical Device

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Microsoft office & Adobe Acrobat GMP and GCP

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Education

2014

MBA: UCCS – Health Care Administration

Colorado Springs, CO USA

2011

Master of Science: Long Island University – Drug Regulatory Affairs

Brooklyn, NY USA

GPA 3.69

2008

Bachelor of Science: Rajiv Gandhi University – Pharmacy

Banglore, Karnataka India

GPA 3.9

Professional Experience

01/2009 - 08/2009

Quality Assurance Associate

Neelkanth PVT. LTD. INDIA Jodhpur, Rajasthan

● Maintained the quality system such as laboratory control, investigation management, documents

and records to ensure the quality of manufacturing process.

10/2008 - 12/2008

Jr. Pharmacist

U N Mehta Hospital of Cardiology Ahmedabad, Gujarat

Worked in In-patient and surgical pharmacies.

Processed and filled prescription and Managed Inventories

Accomplishment: Graduate Assistant, School of Nursing at Long Island University, Brooklyn.

● Taught Undergraduate Nursing Students, Maintaining Grades on BB, Filing, Data entry, Receiving calls

and coordinated scheduling.

Community Service: At present Volunteering at Out-patient Pharmacy at Penrose Hospital.

● Volunteer as Pharmacy Technician at Kala Pharmacy, Brooklyn, New York April 2011- Sept 2011

Processed written prescription, Dispensing drugs, accounted drug inventory, handling patients

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