Quality Assurance Medical

DRASHTI SHAH

** ***** ********* **., ******, MA *2120 M: +1-857-***-**** E:****.**@*****.***.*** LinkedIn: www.linkedin.com/in/drashti-shah7195

SUMMARY

Actively seeking entry-level full-time opportunities in regulatory affairs where more than 1 year of regulatory and quality assurance experience will add value and be productive. EDUCATION

Northeastern University, Boston, MA, United States June 2018 Candidate for MS in Regulatory Affairs of Drug, Biologics and Medical Devices. CGPA: 3.334 Nirma University, Ahmedabad, Gujarat, India May 2016 Bachelor of Pharmacy CGPA: 7.89

EXPERIENCE:

Regulatory Affairs Intern, Modi Antibiotics, Ahmedabad, Gujarat, India August 2015-August 2016

• Managed regulatory documents for IND, ANDA, post marketing surveillance and pharmacovigilance.

• Documented and submitted regulatory filing applications.

• Reviewed amendments and supplements for all antibiotics (CMC and SUPAC).

• Managed and executed compliance activities.

• Performed laboratory tests on herbal plant (N. jatamansi) using ELISA and PCR tools.

• Prepared media for plant tissue culture.

Quality Assurance Intern, Swiss Parenterals LTD., Ahmedabad, Gujarat, India May 2015–July 2015

• Co-operated efficiently in manufacturing unit by assuring compliance with Good Manufacturing Practices (GMP).

• Studied the manufacturing and packaging/labelling regulations pertaining to parenteral formulations.

• Documented standard operating procedures (SOPs) for equipment.

• Assisted quality control department for controlling starting materials, intermediate products, finished products and other in-process controls - calibration, validation for processing. (21 CFR 210, 21 CFR211). SKILLS:

Skills: Ability to demonstrate professional knowledge within RA, QA and manufacturing unit (NDA, ANDA, CMC, PMA, 510 (k), clinical and pre-clinical development of drugs and biologics, GMP, GLP, GCP, packaging, labelling), attention to detail, excellent writing and communication skills, SOP documentation, research and development, HPLC, ELISA, PCR. Software: MS Word, MS Power Point, GOLD, LIGAND DOCK, Accelrysdraw, Chemsketch, Chemdraw. ACADEMIC PROJECTS:

Thesis on “Pharmacological Analysis of Nardostachys jatamansi in ADHD and Alzheimer’s disease.”

• Research based analysis included - overview and pharmacology of both diseases, pharmacognosy, plant profile, structure and chemistry of N. jatamansi, molecular targets in the brain for both diseases, molecular docking and its stages, identified possible targets and constituents for curing both diseases. Mock investigator’s brochure and mock informed consent form.

• Prepared mock Informed Consent Form and Clinical Protocol with FDA Form 1572 form, in compliance with New York State Regulations, Code of Federal Regulation and HIPAA. Medical Device Submission: Regulatory Strategy for: 1) Tridyne Vascular Sealant 2) Restylane Refyne, Restylane Defyne

• Developed a regulatory strategy for the above devices including device description (PMA number, product code, classification of the device), labelling information, pre-clinical and clinical studies, financial disclosures, post marketing recommendations, conditions on approval, PMA supplements and its approval.

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