Quality Assurance Medical

Nidhi Shah

*** *** ***** ****, ******, MA ***** 617-***-**** ****.****@*****.***.***

OBJECTIVE

Seeking an Entry-Level position in the Clinical Research/Regulatory Affairs Arena that will provide me with the opportunity to fully utilize and expand my knowledge of the regulatory agencies and their regulations.

COMPETENCIES AND ACEDEMIC KNOWLEDGE RELATED TO REGULATORY AFFAIRS

Ability to compile and prepare INDs, IND Amendments, forms 1571 and 1572, NDA and BLA application preparation, annual report submissions related to IND/ NDA/ BLA, serious adverse event reporting to FDA and drug safety report Submissions.

Knowledge of ANDA submissions and activities related like annual report, amendments, supplements, 15- day Alert Report, ADRs reporting and maintaining using Med Watch. PAS-Prior and Post approval supplements, 30-day supplements, change control document preparation and IND amendments for generics.

Thorough knowledge of ICH guidelines and NIH regulations for Clinical Trials, Protocol preparation and submission process and regulatory document maintenance, clinical trial regulations related to IRB, submissions, informed consent form preparation and amendments, IRB Package preparation, protocol review and studied international regulatory management of CTs, CT designs.

Essential knowledge of 510(k), PMA, PMA Supplements like 30-day notice, 180-day Supplement, Real-Time reviews, EU CE Mark Submissions, MDD and Medical Device Vigilance regulations. Regulations related to ISO 13485, ISO 14971 (Risk Management System), 21 CFR 820 and Quality Assurance.

Extensive understanding of documentation, especially for handling batched records, SOPs and CAPA, training records, 21 CFR 210 and 211, preparing document control and change control, general documentation for QA Department.

Primary acquaintance of FDA regulations for labeling, advertising, promotional material of drugs, biologics and medical devices, including 21 CFR 201, 21 CFR 801, 21 CFR 809 and 21 CFR 812. Working knowledge of unique device identification regulations and data entry to the global UDI database.

WORK EXPERIENCE

Quality Assurance Analyst September 2016- Present

Ajes Pharmaceutical Copaigue,NY

Responsible for collecting and reviewing QC reports, Batch Manufacturing Records, Deviation Reports, Certificate of Analysis etc. in order to ensure GCP compliant manufacturing activities.

Route the documents, get approvals, issue, make effective and implement. Maintain all GCP records and training records.

Provide on-the-floor QA oversight of manufacturing, QC, and other GMP activities. Support QA Manager identify non-compliance problems and propose solutions. Effectively interact with other functional personnel and assist with resolving quality related issues.

Assist senior staff in maintaining inspections readiness and performing audits.

Responsible for writing, revising and coordinating review and approval of standard operating procedures (SOPs), manuals, and plans.

Responsible for updating compliance archives and preparing documents storage.

Student Nurse (Clinical Rotations) January 2014 – September 2014

University of Detroit Mercy Detroit, MI

Gained vast experience floating to varied medical wards, quickly assimilating into new care team setting, learning new procedures, and adjusting to different environment.

Shadowed experienced RNs managing cares of 3-4 patients in assigned wards (Psychology, Neurology, Medical-Surgical, Critical Care, Ob/Gyn etc.)

Performed all functions related to daily living activities. Responsible for administering PO, IM, IV, SC medication. Handled IVs and dressing changes.

Conducted physical assessments of patients, monitoring and understanding telemetry.

Acquired soft skills and experience that enable me to work with various type of patients while enhancing communication efficiency, documentation skills, time management and prioritization of patient care.

Demonstrated excellent communication with the rest of the member of each patient’s medical team including doctors, case workers, dietitians and PT.

Planet Health Ahmedabad, India

Pharmacist May – August 2011

Advised patients on proper dosage and indication of prescribed medicines.

Performed patient-counseling and dispensed the medicines according to regulatory principles.

Investigated and reported customer complaints concerning the use of the medical devices including blood pressure monitors, electronic thermometers, etc.

Collaborated with physicians to resolve various prescription discrepancies that could lead to adverse events.

Reported adverse side effect of drug interactions to physician and proper authority.

Data entry of medicinal product information accordingly to the pharmacy’s computer database system for the received goods and authorized the indent.

Rajshri Pharmaceutical Ltd. Ahmedabad, India

Quality Assurance Coordinator April 2011-May 2011

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

Inspected and reviewed documentations for labeling of the finished products and released them in accordance with the specific written procedures.

Surveillance of production site on regular bases and reported contamination and packaging deficiencies to ensure product quality and safety.

EDUCATION

M.S. Regulatory Affairs for Drugs, Biologics and Medical Devices (On-going) August 2015 –Present

Northeastern University Boston, MA

Regulatory affairs writing

New Drug Development

Biologics Development

Food drugs & medical devices Law

Management of International Clinical Trials

Human Experimentation and Methodological Issues

Biomedical Product development

Emerging Trends in Medical Device Industry and Issues

Generic Drug Development

Bachelors of Pharmacy September 2007 – April 2011

Gujarat University Ahmedabad, Gujarat, India

Pharmaceutical Sciences

Industrial and Clinical Pharmacy

Medicinal Chemistry

Analytical Chemistry

Bachelor of Nursing (Withdrawal in good standing) January 2014 – September 2014

University of Detroit Mercy Detroit, MI

Introduction to Nursing Practice

Health Assessment and Physical Examination

Mental Health of Adults and their Families

Fundamentals of Adult Health Nursing

Patho-Pharmacology (I & II)

Population Health and Epidemiology

Health Restoration in Adults (I & II)

Nursing Research and Evidence Based Practice

Nursing Leadership

Online Pre-requisites for Nursing May2013 – September 2013

Clovis Community College Clovis,NM

Human Psychology

Advanced Psychology

College Algebra

Sociology

Online Pre-requisites for Nursing May 2012 – May 2013

Schoolcraft College Livonia,MI

Biochemistry

Anatomy and Physiology

Microbiology

Organic Chemistry

Nutrition

English.

EDUCATIONAL ACHIVEMENTS.

Certificate of achievement for Schoolcraft College

Dean’s Honor List Schoolcraft College

PHI THETA KAPPA HONOR SOCIETY top 10% Achievement Award

Dean’s Honor List University of Detroit Mercy.

Licence:

PROFESSIONAL LICENCES/CERTIFICATIONS/MEMBERSHIPS

Registered Pharmacist (June 2011) with the Gujarat State Pharmacy Council - Ahmedabad, India.

Current CPR Certification

CDERLearn and CDRH Module Completion Certifications

Professional Memberships:

Regulatory Affairs Professionals Society (RAPS)

LANGUAGES/SKILLS

Fluent in English, Hindi and Guajarati

Computer skills: MS Office, Document Management Systems (primary knowledge), Adobe Acrobat

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