Quality Assurance Control

NIYATI DILIP DAVE

** ****** **** ******, *********# 13 *********@*****.***

Boston, MA 021**-***-*** 9417

Self motivated and team oriented Regulatory Affairs professional, possessing good interpersonal and communication skills. A diligent candidate having a strong regulatory, clinical and quality assurance background combined with an ability to apply the knowledge of FDA, EU and ICH regulations into practical work environment. An individual who exhibits an aptitude to broaden the perspective of the allocated responsibilities and generate improved outcomes.

EDUCATION

Northeastern University, Boston, MA April 2012 College of Professional Studies

• Currently Pursuing Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices

Relevant Coursework: Regulatory requirement for Drugs, Biologics and Medical Devices, Practical Aspects of Regulatory Compliance, Human Subject Protection Regulations

• Member of RAPS

University of Mumbai, Mumbai, India June 2010

Dr. Bhanuben Nanavati College of Pharmacy

• Bachelor of Pharmaceutical Sciences

• Received an Educational Scholarship from J.N.TATA Endowment

REGULATORY PROFICIENCIES

• Familiarity with Code of Federal regulations Title 21, ISO 13485 Standards, ICH Guidelines, GMPs, GCPs and GLPs

• Knowledge of EU compliance regulations, European Medicines Agency (EMA), EU Directives and CE Marking requirements for medical devices

• Conceptual understanding of Quality systems regulations and design control process for medical devices

• Working knowledge of PMN, PMA IDE, Off – label use of medical devices, Combination Products and In- Vitro Diagnostics, Post Market Surveillance

• Adept in the concepts of Clinical Trials and Informed Consents, Product Recall and Safety Alerts, Risk Analysis, Quality Assurance, Quality Control, Standard Operating Procedures (SOP),BMRs.

• Practical application of IND, NDA and ANDA, BPCA, PREA. Orphan Drug designation, Fast Track Approval for drugs, BLA, Biosimilars. Form 1571, Form 1572, Form 2253, form 356h

• Well versed in basic Computer software: Microsoft Office Suite (Word, Excel, PowerPoint),Windows and Internet knowledge

ACADEMIC PROJECTS September 2012- Present

Quality Management Systems

• Compared the four quality systems ICH Guidelines, ISO 13485, Q10 Pharmaceutical quality systems, cGMP for Combination products, and 21 CFR part 820: Quality Systems Regulations

Off–Label Use of Medical Devices

• Researched and presented a paper on Off–Label Use of Medical Devices addressing the regulatory challenges and ethical considerations

Investigational Device Exemptions

• Delivered a seminar on Rights to Access Investigational Devices discussing the requirements for the appropriate and ethical use of devices which have not been approved for marketing

IRB (Institutional Review Board) Memorandum

• Generated an IRB Memo for senior leadership for the creation of an IRB pursuant to Federal Regulations and practical implications

Informed Consent

• Prepared an Informed Consent Document involving ‘Infliximab’ in the treatment of Resistant Major Depression. Drafted an accompanying information sheet in accordance with 21 CFR Part 50.25(a)

Quality Assurance Case Study

• Drafted a paper on responsibilities of the Quality Assurance unit, highlighting their role in maintaining Quality Control, preparing SOPs and developing protocols for clinical studies in compliance with the FDA regulations

Biologics License Application

• Compiled a mock BLA submission based on the regulatory approval process for the product ‘Corifact’ in accordance to the 21 CFR 601.2 and form 356h

Regulatory Development Plan

• Created a Regulatory Development Plan to obtain marketing approval of a fictitional drug in accordance with 21 CFR 312 and FDA guidance Documents

Pre-IND Meeting Request

• Prepared a mock meeting request application for submission to the FDA in accordance with 21 CFR § 312.82 and FDA Guidance Documents

RELATED WORK EXPERIENCE

Summer Internship at Renumed Pharmaceutical Lab, Mumbai, India May 2009 – June 2009

• Handled SOPs, created BMRs and DMFs, Performed Process Validation and Equipment Validation

• Gained hands on experience in Analytical Techniques, Quality Assurance and Quality Control procedures for product development in accordance with the FDA regulations.

• Assisted in the formulation and manufacturing of drugs like Paracetamol, Sildenafil and Ibuprofen tablets

LEADERSHIP EXPERIENCE

Supervisor, Residential Safety Office, December 2010- Present

Northeastern University, Boston, MA

• Supervised and coordinated a team of proctors to maintain decorum and a disciplined environment at campus dorms

• Served as a liaison between the students, college security staff and campus representatives

Representative, College Cultural Council. September 2006- May 2010

Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, India

• Organized cultural events and festivals among various colleges

• Coordinated a team of more than 50 members participating in various cultural events

TECHNICAL PAPERS AND RESEARCH

• Designed and conducted a research to evaluate the Antimicrobial activity of leaves and root extracts of Embelia Tsjerium cottom against dental pathogens February 2010

• Carried out a research on Antifungal activity of selected plant extracts against human fungal pathogens for poster presentation at the 61st Indian Pharmaceutical Conference. November 2009

• Presented a seminar on the topic of Translation of proteins and Drug Targets January 2009

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