Quality Control Medical

KEDAR PAI

**** ********* ***** ***: **, Los Angeles, CA-90007 (H) 213-***-**** (E)

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

PROFESSIONAL SUMMARY

Highly motivated graduate student eager to launch career in driving quality

assurance/ regulatory affairs in the healthcare industry. Focused,

meticulous emerging professional with hands-on knowledge in fields of

biologics and pharmaceutical product regulations and quality systems

seeking internship and full-time position in a leading Biotechnology/

Pharmaceutical company.

EDUCATION

Masters in Regulatory Sciences, University of Southern California

Class of 2014

Coursework: Quality Systems and Standards, Regulation of Drugs, Biologics

and Medical Devices, Design and Management of Clinical Trials, Chemistry

Manufacturing and Controls, Medical Product Law, Safety evaluation during

drug development

Certificate in Pharmacovigilance (RAPS)

July 2013

Coursework: Operational activities within drug safety departments, drug

safety reporting requirements, PSUR, Periodic reports, Periodic Benefit-

Risk Evaluation Report, Europe Good Pharmacovigilance Practices,

Pharmacovigilance in special populations

Bachelors in Pharmacy, Manipal College of Pharmaceutical Sciences

May 2012

Coursework: Biomedical and Pharmaceutical Analysis, Industrial Pharmacy,

Pharmaceutical Technology, Pharmaceutics, Pharmaceutical Biotechnology,

Pharmaceutical Jurisprudence, Pharmaceutics, Pharmaceutical management

RESEARCH PROJECTS

Clinical Trial Protocol-Phase IV, University of Southern California

Spring 2013

. Prepared an FDA submission-ready Phase IV protocol of Gabapentin as a

prophylactic agent for migraines with/without aura

. Assisted in determining primary and secondary outcomes for the study,

constructed Informed Consent Forms for patients

. Determined Power analysis and Sample Size for a multi-center clinical

trial based on primary and secondary endpoints of study

Project Head-USFDA submission of biologic, University of Southern

California Fall 2012

. Formulated a sub-cutaneous injection for biologic to treat patients with

obesity in comparison to current anti-obesity drugs

. Strategized an IND application based on 21 CFR part 312, BLA in

compliance with 21 CFR part 314 and patent filing of biologic

. Conceived a project plan from bench to commercialization, outlining key

milestones, timeline and financial projections

Pre-market Notification- 510k Submission Packet, University of Southern

California Fall 2012

. Determined predicate device for class II implantable clip for ligation of

blood vessels and healing during endoscopic procedures

. Demonstrated Design Verification, biocompatibility and packaging testing

of clip in compliance with ASTM and ISO standards

. Drafted the labelling and IFU for implantable clip in accordance to USFDA

and proposed regulatory pathway required.

Article on Online Pharmaceutical Marketing in PharmaBiz, Manipal University

Spring 2012

. Developed an article highlighting the impact of Social Media and the

World Wide Web on Pharmaceutical Marketing

. Identified the popularity and advantage of online marketing over

conventional marketing modalities of healthcare products

PROFESSIONAL EXPERIENCE

Regulatory Intern- Teco Diagnostics, USA

Sep 2013 -

present

. Carried out various quality control tests and documentation of URS

(Urinary Reagent Strips) and chemical diagnostic reagents

. Assisted in preparation of U.S. and international regulatory filings and

registrations for class I and class II medical devices

. Participation in various QA functions related to documentation, training,

CAPA and deviation, and audits

Quality Intern- Abbott India, Goa, India

Dec 2010-Jan 2011

. Monitored various manufacturing and quality control activities in non-

sterile liquid formulation and tableting unit for antacids

. Documented and assisted in chemical assays of raw material and finished

product using MS-GS and neutralization titration

. Examined and observed validation and verification of quality control

tests, raw material and finished product assays

Research Assistant- Manipal University

Jan 2012- June 2012

. Received extensive training in developing skills of new drug discovery,

under supervision of medicinal chemistry department

. Worked on flavone derivatives and carried out QSAR studies to develop a

molecule with anti-cancer properties

. Carried out various chromatographic techniques, UV and IR spectroscopy to

differentiate various flavone derivatives

AFFILIATIONS, SKILLS AND INTERESTS

. Thrive in environments requiring organization, strong communication and

presentation skills- MS Office, JavaScript and HTML

. Member of RAPS, member of ISPOR- head of meeting and planning committee

of KSPOR 11-12(Student chapter of ISPOR)

. Attended conference on UDI and Traceability of medical devices and

volunteered at the MD&M Conference 2013, Anaheim

. Sports: Soccer captain for college at several state competitions,

Taekwondo black belt, three time state silver medallist

. Volunteered and attended the IPC(Indian Pharmaceutical Congress),

Manipal, India, December 2010

Contact this candidate