Quality Assurance Medical Device

Kshitij R. Prabhune

*********@*****.*** / 857-***-****

www.linkedin.com/in/kshitij-r-prabhune

Address: *** ******* **, ********** ** 02145

1

EDUCATION

MCPHS University, Boston, MA

Master of Science in Regulatory Affairs and Health Policy (GPA: 3.8) September 2015-May 2017 Thesis title: A comparison of the regulation of Alzheimer’s disease biomarkers among founding members of the International Council of Harmonisation: Perspectives from the United States, European Union and Japan. Relevant Course work: FDA and Health Policy, Food and Drug Law, Medical Devices Regulations, International Regulatory Affairs, Human Experimentation, Quality Assurance and Quality Control, Health Epidemiology. Dr. L. H. Hiranandani College of Pharmacy, Mumbai, India Bachelor of Pharmacy (GPA: 3.1) August 2010-July 2014 Course work: Novel Drug Delivery Systems, Pharmaceutics, Pharmacology, General Chemistry, Pharmaceutical Analysis, Anatomy and Physiology, Biochemistry, Forensic Pharmacy. SKILLS

• IND, NDA, 510(K), PMA, BLA, IDE, 21 CFR, ICH, ISO 13485, International Regulations, EU Directives,

• Regulatory Technical Writing, Punctual, Team Player, Corporate Communications,

• ICF, GxP, Quality Assurance, Medical Affairs, Market Research, Summary Technical Document (STED),

• Strategic planning in regulatory submissions, Critical analysis of issues, Work efficiently under stress. PROFESSIONAL EXPERIENCE

MCPHS University, Boston, MA

Graduate Assistant, Postdoctoral Biopharmaceutical Industry Fellowship Program June 2016-May 2017

• Provided administrative support for the program.

• Monitored fellowship activities by tracking records and updated fellow profiles using New Innovation software.

• Assisted in planning networking events and maintained a database of program requirements.

• Reviewed and managed processing reimbursements of enrolled fellow. Proctor, Disability Support Services September 2015-May 2017

• Acted as exam proctor for students with special needs. Peer tutor, The Center for Academic Success and Enrichment Department February 2016-August 2016

• Tutored undergraduate BS in Pharmaceutical Sciences students in Organic Chemistry. Gebbs Healthcare Solutions, Mumbai, India

Trainee Medical Coder February 2015-May 2015

• Coded medical reports to expedite healthcare reimbursements.

• Applied CPT and ICD 9 medical coding guidelines for US based clients.

• Maintained accurate quality records and delivered daily targets. Ipsos Research Private Limited, Mumbai, India

Syndicated Healthcare Research Associate June 2014-January 2015

• Compiled and analyzed data on multiple therapies and drug treatments for cancer.

• Successfully contributed to market forecasts by implementing data analysis techniques.

• Communicated with oncologists and validated the real time information on applied cancer regimens.

• Performed quantitative data analysis of Chronic Myelogenous Leukemia (CML) studies. Pharmaceutical Products of India Limited (P.P.I.L), Mumbai, India Intern May 2013-June 2013

• Validated purity, concentration, and sample sizes of final products for Quality Assurance department.

• Documented inventory records and manufacturing procedures for Production and Packaging departments. Kshitij R. Prabhune

*********@*****.*** / 857-***-****

www.linkedin.com/in/kshitij-r-prabhune

Address: 110 Perkins St, Somerville MA 02145

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PUBLICATION

Promoting the culture of quality in Pharmaceutical Industry in India (submitted manuscript)

• Currently working towards final draft which will be published in Regulatory Affairs Professionals Society

(RAPS) Focus magazine.

• Conducted a literature review for qualitative data on regulatory processes, compliance and quality standards followed by Quality Assurance departments in pharmaceutical quality in India. PROJECTS

A Behavioral Therapy for Insomnia Co-existing With COPD

• Performed regulatory review for ongoing clinical trial and drafted Informed Consent Form (ICF).

• Developed an innovative concept for a mobile application to assist clinical trial subjects to comply with trial protocol and maintain records.

Orphan Drug Designation Process and Pediatric Drug Development Process

• Collaborated on a systematic review of Regulatory pathways for Orphan Drug Designation Process in EU and Australia.

• Compared and contrasted regulatory submission processes for EU and Australia.

• Analyzed regulatory requirements for combination product for Aplastic anemia in pediatric use in the US. Medical Device Development Strategy

• Analyzed Class II medical device regulations [510(k)].

• Devised ‘Lab on a chip’ medical device development strategy and regulatory registration process. Bacterial Enzyme as an anti-HIV agent

• Presented and won a national competition with a working model related to Bacterial Enzyme as an anti-HIV agent.

• Built a working model demonstrating bacterial enzyme’s mechanism of action. Novel approaches for Malaria treatment

• Placed second in a state competition with a poster presentation related to Malaria treatment.

• Performed literature review to gather qualitative information and analyzed to devise a novel pharmacological approach

LEADERSHIP EXPERIENCE

Indian Pharmaceutical Association-Students’ Forum-Maharashtra State Branch (IPA-SF-MSB) Council Associate Public Health Officer May 2012-April 2014

• Actively created Public Health Office resources.

• Planned and executed healthcare awareness campaigns on campus and in nearby communities.

• Organized blood donation drives on campus for students and faculty.

• Worked on promotion of Pharmacy as a profession to high-school students and general public during the National Pharmacy Week.

Cell member, Student Exchange Committee August 2011-April 2012

• Implemented Intrastate Student Exchange Program, Hospital Pharmacy training, Community Pharmacy training, Industrial visits and blood bank visits.

• Recruited sponsors to fund IPS-SF-MSB sponsors.

Dr. L. H. Hiranandani College of Pharmacy, Ulhasnagar, India Student Council August 2010-April 2014

• Served as liaison between IPA-SF-MSB and college, students and faculty.

• Helped current students connect with alumni from industry and academia through professional networking.

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