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Microsoft Office Medical Device

Location:
Marlborough, Massachusetts, United States
Posted:
May 31, 2017

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EDUCATION:

Masters in Regulatory Affairs for Drugs, Biologics, and Medical Devices September 2014 - 2016

Northeastern University, Boston, MA 45 credits completed

GPA: 3.7/4.0

Bachelors of Pharmacy

Rajasthan University of Health Sciences, Udaipur, India September 2007 - August 2011

GPA: First division with 70.33%

PROFESSIONAL KNOWLEDGE:

Knowledge of US FDA regulatory submission requirements for IND, NDA, BLA along with an understanding of medical device regulations including Pre-market Approval (PMA), Investigational Device Exemption (IDE), 510(k), HUD, and HDE. ICH Guidelines: FDA CFR Title 21, 21 CFR 210 and 211-(CGMP), part 11-Elecronic records and documentation, CAPA, Validation, Change control system, 13485, ISO 9001, CLIA and EIA, GLP and GCP, clinical trials, IRBs, informed consent, patient recruitments, and Investigator brochure, SABA, File maker pro, Master Control, Track wise, Share point, Hyper care, infolinx, LIMS, Microbiology assay, CAPA, Audits, EDMS, JD Edwards 1, Compliance wire, Veeva.

PROFESSIONAL EXPERIENCE:

Quality & Regulatory Associate, Pure encapsulations (Dietary supplement) May 2016-Current

Involve in NDI (New Dietary Ingredient) Project-Regulatory

Releasing and Filling Finished Product Work Orders

Prepare sample submission forms-The lot master in JDE will show which ingredients were received

Involve in CAPA, Supplier qualifications, FDA audits, Product complaint, Training system

Make flow chart for SOPs, Production batch record review, Resolve HR issues within Quality Department, Check and supervises training requirements for employees

Review and upload Laboratory Certificates, Stability reports and Test Results in Veeva tool

Assure to compliance with Quality and industry Regulatory requirements

Perform to daily tasks given by Director of Quality Assurance

Manage Document Change order Process with the Veeva Vault tool

Responsible for review and approval of Specifications (Component, Ingredient, Material)

Other duties as assigned

Quality Document Management Coordinator-Co-op, Shire, Lexington (Pharmaceutical firm) July ‘15-December 2015

Daily documentation processing of SOPs, Batch Records, Material Specifications, Product Specifications and Formulation Preparation Sheets to assure cGMP compliance in all site-specific & globally effective documents

Updating and maintaining the controlled document database with regular filing and archiving activities -Mastering, Obsoleting documents with data extraction, manipulation of data for reports

Review packages for accuracy and conformance to established guidelines, polices, and practices.

Formatting to structure record and data entry work using Microsoft office word

Advise and respond to queries on document status and document related projects by interfacing with customers.

Trainee at YASH Medicare Pvt. Ltd (Pharmaceutical firm) February 2011 - May 2011

Acquired comprehensive knowledge of WHO guidelines and regulations for GMP and cGMP

Responded to any product quality complaint as per Standard Operating Procedure (SOP)

Coordinated with Quality Assurance, Formulation & Development departments to reviewed technical documents such as Process Validations, commercial manufacturing, packaging and raw material specifications

Learned to handle various machineries including rotary tube filling, crimping machine, high speed automatic head, triple head container filling machine and container capping machine

ACADEMIC PROJECTS (Northeastern University, Boston, MA):

Rationale for Class-II Medical Device Classification and procedure for 510 (k) submission Fall Term, 2014

This Project demonstrated the ability to classify a medical device and navigate through the procedure of filing a 510 (k) application.

Some of the questions that this project answered are: Why is a device classified as Class 2? What are the prerequisites for filing a 510(k)? Whether non clinical and clinical data needed for filing this 510(k)? What are predicate devices? Is the device a Class 2 exempt device?, What are the Guidance Documents available for submission of this 510 (k) application?

Investigator Brochure of a Phase 2 drug Fall Term, 2014

Preparation, submission and presentation of an Investigator Brochure for a Phase 2 drug. The learning out of this project include comprehension of the important elements of an IB, utility of Good Documentation Practices (GDP), team player skills, process of conducting clinical and non-clinical studies.

ACHIEVEMENTS/CERTIFICATES:

Received certificate and first prize in quiz competition in National Pharmacy week (Certificate).

Conducted an awareness rally for safe and rational use of drugs.

COMPUTER SKILLS/Lab skills:

Microsoft Office Products (Word, Outlook, Excel, PowerPoint, Access, Project)

Flame photometer, Double beam spectrometer, HPLC (high performance liquid chromatography)



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