Microsoft Office Assistant

KRIPA H. PATEL

973-***-**** . **********@*****.***

EDUCATION

Long Island University, Brooklyn, NY 3.73/4.0 CGPA Master of science in Drug Regulatory Affairs, Dec 2017 Charotar University of Science and Technology, Changa, India 8.09/10.00 CGPA Bachelor of Pharmacy, May 2015

SKILLS

• In-depth knowledge about regulatory submissions of IND, IMPD, NDA, BLA, 510k, GMP, cGMP, ICH, CBE0, CBE30

& HIPPA guidelines.

• Well versed with FDA forms, QSR, Annual Safety Report, Adverse drug event reporting, eCTD submission process.

• Knowledge of Title 21 of CFR (parts 11, 50, 56, 201, 202, 211, 212, 312, 314, 800, 801, 803, 820)

• Well informed about Companion Diagnostics, Medical devices and its class submissions, risk management, handle customer and client complains, ADR under FDA part 803, Annual Product Review- APR submissions.

• Preparation of SOPs and handling instruments, production, packaging, labeling and storage of generic drugs and dietary supplements.

• Well informed about Food safety regulations, USDA and FSIS regulations and requirements.

• Strategic execution of relevant CAPA associated with drugs products and medical devices.

• Proficient in Microsoft Office, Word Processing, Spreadsheet.

• Excellent verbal and written Communication Skills. EXPERIENCE

Aquila Labs, Gujarat, India Dec 2013 –Dec 2015

QA Associate

• Worked as a QA associate for 2+ years for labeling of generic drug formulations and dietary supplements.

• Ensure and promote compliance with current good manufacturing practices as applicable by FDA.

• Review, Preparation, validation and maintaining SOPs and specifications.

• Designing labels, nutrition facts label for drugs and dietary supplements.

• Regulating changes and updates in the labels and labeling.

• Responsible for labeling and packaging of finished products.

• Collect and test samples from production lots as a part of in-process quality control testing and retention storage requirements are met.

• Perform internal audits, designing and executing specific modifications to adopt specific CAPA.

• Interact with customers to support customer audits. Graduate Assistant at Long Island University

• Worked as an assistant in Pharmacology.

• Handling and working with animals for the research work.

• Maintaining and updating records, SOP for ongoing research. PROJECTS

Preparation of IND Application

• Prepared an Investigational New Drug Application as a project for class of Mechanics Preparing INDs and NDAs.

• Assembled and arranged all the forms required for the submission of an IND Application in accordance with their respective modules.

• Designed a clinical strategy, inclusion and exclusion criteria for screening of patients, diagnostic techniques to carry out clinical trials on Phase 2 study.

Comparative pathways for application in EU, CANADA, US and JAPAN

• Comparison on the application pathways for application and fast track and expedited pathways for application for approval of new drugs and medical devices around the globe, with focus on EU, JAPAN, CANADA & USA

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