Medical Device Management

Karunavati Nabar

**** ***** ******, ******* *****, CA, 90278 *********@*****.*** 857-***-****

EDUCATION:

Northeastern University Boston, MA Mar 2015 Master of Science in Drug Regulatory Affairs

Course Work: Human Experimentation, Drug and Medical Device Regulation, Medical Device Development, New Drug Development, Biologics Development, Food Drug and Medical Device Law, Regulatory Documentation

Mumbai University, Mumbai India June 2011

Bachelor of Pharmacy with Honours Course Work: Pharmaceutical Sciences, Pharmacology, Clinical Pharmacy, Forensic Pharmacy

SKILL SET:

Quality Management: EDMS, ISOTRAIN, ComplianceWire, WebTraining, Good Documentation Practices, Document Management Process, Technical Writing SOPs, WIs, and controlled documents, LiveLink, Trackwise

Regulatory: Proficient knowledge about GxP Regulations, FD&C Act, IND, NDA Applications, ICH guidelines, HHS regulations, 21 CFR 200,400,800

Computer: Proficient in Microsoft Office (MS Word, Excel, PowerPoint & Outlook), basic SAP, SABA (Learning Management System), Share Point

EXPERIENCE:

GlaxoSmithKline, Cambridge, MA April 2015-Present

Global Document Systems Specialist

Documentation & Training

Review and ensure a smooth workflow for Regulatory and Quality documentation

Involved in the Control, Creation and Update of controlled documents such as SOPs and WIs

Actively involved in separation and withdrawing of company specific and shared documents

Update the document Flight Board and track overdue compliance activities

Initiate document control workflows and provide support to end users in the Document Workflow process

Maintain Monthly Quality report of Compliance Activities of all the departments

Support Global Document Management by administering and supporting the maintenance of MSOPs, GSOPs, and other globally owned Controlled, Managed and Validation documents

Subject Matter Expert in use of electronic systems and publish documents in EDMS and SharePoint

Responsible for support of Global document authors and owners. Guide, coach, direct and help standardize adherence to the MSOP Review and Approval process and document templates

Provide consistent metric updates and communications to Quality Systems and Standards and QALT as needed including; MSOP/GSOP periodic review and Approval timelines

Perform periodic user review, periodic maintenance and periodic review of global documents

Coordinate Third Party User Requests

Interface WebTraining and EDMS to initiate training once documents are made effective

Baxter Healthcare, Milford, MA Oct 2014-Jan 2015

Document Control Specialist

QA & Regulatory Affairs documentation

Assisted in the designing of lot package checklist for final batches of the product

Reviewed and scanned Quality Project Plans in SharePoint in the respective folders of Quality Management System

Integration

Support Baxter’s electronic document management system (EDMS) by maintaining documents

Reviewed Document Change Request forms of various divisions such as Quality Control, Manufacturing, Facilities and Technical Maintenance

Reviewed executed production batch records in order to design the chain of custody for final batches

Reviewed Master Manufacturing Instruction Request and Issuance Form for record of late entries if any

Updated training records of employees according to the format offsite in the grey space

Involved in archival and updating of documents such as training records onsite and offsite.

Micro Labs Limited, Mumbai,India Nov 2011-Nov 2012

Regulatory Affairs Associate

QA & Regulatory Affairs documentation

Raised document change request for approved GMP documents during periodic review

Provided documentation support for ANDA regulatory submissions.

Initiated the transfer of documents to current document owner and workflow submission form requirements.

Ensured completeness for a smooth edit & review of regulatory documents by mastering process for workflow submission.

Reviewed regulatory submissions for international markets while balancing multiple priorities.

Implemented electronic document process along with developing dashboards and ensured document traceability.

Coordinated with the R&D department for formulation and analytical documents for regulatory submission

Adequately defined and documented support for cross functional departments for design control and design transfer.

Ensured customer satisfaction for various company products and submissions.

Entered document specialist daily tracker information onto the appropriate tracker spreadsheet for Monthly metrics.

Johnson & Johnson, Mumbai, India Jun 2011-Aug 2011

Pharmacovigilance Intern

Analysis of Case Report Forms (CRF’s)

Maintained required records of study activity including CRFs or regulatory forms

Assisted in preparation of study related documentation such as protocol worksheets and adverse event reports

Involved in scanning & shipping of PDF documents to the concerned agency for review.

Data entry of adverse events received from doctors in an excel database

Arex Laboratories, Mumbai, India Jun 2010-Jul 2010

Trainee

Training and Development of Pharmaceutical Processes

Performed quality control tests for tablets and capsules according to GMP & GLP guidelines

Participated in train the trainer and certify internal auditor program at site to provide certification to trainer and internal auditors.

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