Quality Assurance Medical

Hema Naik

Cell: 919-***-**** ***********@*****.***

Looking for an opportunity in field Drug Safety/ Quality Assurance / Regulatory Affairs / Clinical Trials

Education:

MS in Biotechnology Specialized in Regulatory Affairs from University of Maryland University College, GPA 4.0/4.0

Diploma in Biotechnology with Honors – Montgomery College, Germantown, MD

BS in Ayurvedic Medicine and Surgery- 5 Years Study & 6 Months Internship

Awards:

Member of the Honor Society of Phi Kappa Phi

UMUC’s President Scholarship fall 2016

UMUC President Grant - fall 2015, spring 2016

Dean’s List Candidate - Montgomery College - spring 2014 & fall 2014

MD Bio Scholarship Award

Member of society of Quality Assurance

Biotechnology Certificate Courses:

Introduction to Biotechnology

Cell Culture.

Protein technology

Instrumentation in Biotechnology

Nucleic Acid and Methods.

Immunology and Methods.

Biotechnology Non-Credit courses:

Business Communication

Process Improvement

Protein Purification

GLP Certification with 12 hours training

Green belt Six Sigma Process

Improvement

Biotechnology Graduate Courses:

Societal Issues of Biotechnology

Techniques of Biotechnology

Introduction to Bioinformatics

Bioprocessing and the Business of

Biotechnology

Foundations of Project Management

Global Biotechnology Business Issue

Preclinical & Clinical Research Design

Product Life Cycle

Practical applications of Biotechnology

Capstone in Biotechnology

Biotechnology Regulatory Environment

Skills Acquired during my jobs and Biotech Graduate courses:

Followed Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and current Good Manufacturing Practices (cGMP) established by the FDA, ICH, and WHO.

GLP as per the U.S. FDA CFR 21 Part 58 and the Organisation for Economic Co-operation and Development (OECD).

Knowledge of regulatory risk evaluations and risk mitigation strategies.

Acquires, analyzes and evaluates clinical trial data gathered during research and assures accurate and complete documentation of scheduled protocol studies.

Learned and got exposure to clinical therapeutic areas: infectious disease, cardiovascular disease, oncology, dermatology and medical devices.

Knowledge of Regulatory submissions including Investigational New Drug Application (IND), New Drug Application (NDA), BLA and Pre- marketing approval for Medical Device.

Knowledge of Clinical Trials Data Monitoring, Clinical Trial Management, Patients Enrollment.

During graduate courses exposed to technical writing experience which includes: Standard Operating Procedures (SOP), Operations Manuals and procedure/guidance documents.

Good hands on experience of upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.

Theoretical knowledge about Phase I to Phase IV Clinical Trial as per the FDA and EU regulations.

Good catch to identify errors and potential issues and alert supervisor for further action.

Experience in performing various aspects of document control including but not limited to creating, reviewing, formatting, preparing Current GMP documents.

Familiar with The European Medicines Agency’s Clinical Trials Database (EudraCT) and FDA’s Clinical Trial.gov websites.

Familiar with Medical Terminology related to diagnosis, treatment and adverse drug effect.

Compared current documentation and labeling for compliance with FDA and ISO regulations.

Reviewed advertisements for compliance.

Helped preparation for 510k and Design Dossier.

Regulatory information for entry into foreign countries.

Utilized outside resources for research and keeping updated various regulatory research, organization and clerk duties

Instruments - Equipment’s skills:

Spectrophotometer, Centrifuge, Spectroscopy, Chromatography, Bioreactor process

Computer Skills:

MS office, Excel,Word,Power Point, Windows XP, Windows -7, Windows-8,Ethernet Network configuration, TrackWise.

Basic computer troubleshooting, email management.

Professional Experience:

Quality Assurance Auditor Jan 2017- June 2017

Alizee Pathology LLC.

Auditing Pathology and Histology Data. Generating a Data Review Report and issuing Final Study Reports.

Preparing Project Status Report and performing Critical Phase Inspection.

Communicating with Clients for Project Status Report, Protocol and Amendments.

Reporting Study Director for the Deviation of the Protocol.

Preparing a Master Schedule for Projects.

Follow Good Laboratory Practice and Monitoring SOPs and Protocols.

Holding and Coordinating a Quality Assurance Unit Meeting with Laboratory Staff.

General Physician

Pooja Clinic, Gujarat, India Jan 1992 – May 2012

Prepared patients records, arranged - appointments, patients personal history, and patients treatment records.

Instructed assistant and management of Clinic personnel.

Experience of treating male infertility. Sperm count increased after given treatment.

Involved in Clinical trial of the drugs with pharma companies using dose management.

Toxicology studies of drugs with pharma companies.

Medical Officer

Lockhat Sarvajanik Hospital, Gujarat, India Jan 1990 - Dec 1991

Worked in various departments gynecology, pediatric, medical, surgical, operation theatre. Prepared patients records, arranged - appointments, patients personal history, and patients treatment records. Evaluated different diagnosis and treatment options for Asthma, Cardio Vascular Diseases and Diabetes.

Work Eligibility: US Citizen

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