Document Control Clinical Research

VAMSI PRIYA VANGIPURAM Cell : 813-***-****

*** ********* ***, *********, ** Email: ac8tsi@r.postjobfree.com Objective: Self-Motivated, reliable, and experienced professional in the field of Quality Assurance and Regulatory affairs with Drugs and Medical Devices. Interested in applying my creativity and style to my work, a niche that best describes me by connecting Arts and Science, which both describe my passion.

Education:

Professional program in Regulatory affairs from UC Berkeley Extension 2017-2018 Advanced Course in Clinical Research from Anna University & Apollo Hospitals, India 2013 Master of Science in Biomedical Genetics from Vellore institute of Technology, India 2010-2012 Bachelor of Science in Advanced Zoology and Biotechnology from Madras University, India 2007-2010 Languages: English, French, Hindi (Indian), Telugu (Indian), and Tamil (Indian). Professional Experience:

Nidek Inc Sep 2017 –Present

Quality Assurance Specialist

Responsible for various aspects of the Quality Assurance systems including: CFR and other regulatory compliance, internal audits, corrective and preventive actions, document control, complaint handing as well as process validation.

• Responsible for Complete and accurate maintenance and reporting of Medical Device Reports (MDRs) as required by regulatory agencies.

• Performed detailed investigation of adverse events, including review of device data, to determine relationship between the event and the device.

• Performed CAPA initiation, investigation, plan of action, and implementation.

• Responsible for the review, evaluation and closure of customer product complaints and ensured that all product complaints are processed in accordance with established company procedures and standards.

• Performed Collective analyses of product complaints and MDR reports for trends and identification of potential corrective and preventive actions.

• Worked with all Relevant Departments, international and legal representatives, to perform detailed investigation of MDR

• Managed Non conformance process, Maintained product logs, worked with technical resources to determine resolutions, documented disposition of nonconforming product in conjunction with technical Italy & Japan.

• Supported risk assessments and/or escalated investigations by performing complaint reviews and Contributed in continuous improvement initiatives.

• Updated and revised standard operating procedures and its associated change control initiations.

• Worked on software validation activities of eQMS (Master Control) and product recalls as needed.

• Participated in management reviews on the performance of the QMS to top management and corporate compliance, including need for improvements in scope of complaint handling and MDR.

• Participated in inter and intra departmental projects and improvement initiatives which includes but not limited to streamlining SOPs, processes and collaboration with other groups to continuously improve. MD Resource Corporation

QA/RA Associate Mar 2017- Sep 2017

Acting in a leadership role as Management Representative in all aspects of the Quality & Regulatory Operations including: Regulatory Strategies and Submissions, Management Review, Design Control, Document Control, CAPA, Nonconforming Product, Complaint Handling, Labeling and Packaging Control, Training, Auditing and Supplier Qualification.

• Experience with change request, CAPA, non-conformance reports, investigating customer complaints, conducting root cause analysis and risk analysis.

• Prepared communication and resolution of any non-conformances and warning letter observations notified bodies audits (ISO & CMDCAS) and have performed successful corrective actions.

• GMP Document Control - Initiate, approve document change control records and route them on eQMS.

• Conducted Product release, Issue and collect working device history records for Manufacturing.

• Assisted in maintaining company's document control policies, revision and initial release of documents and training affected department personnel on the changes.

• Supports the Quality Management System and Quality Policy of the company. Helped clients with any Regulatory related concerns, new supplier evaluation and approval.

• Experience with maintenance of Device Technical File, Device History Records, Device Master Record and Design History File.

• Provided technical guidance and regulatory training to other RA employees and cross-functional teams by maintaining a training Matrix.

• Assisted in Obtaining certificates (CFG) and their authentications and legalizations needed for regulatory filings.

• Participated in product development cross-functional teams, provided regulatory strategy and support.

• Evaluated proposed product modifications and their regulatory impact.

• Experienced with establishing and maintaining the documentation library.

• Assisted with establishing, publishing and improving key performance metrics related to document control.

• Worked with the team in the event of an Internal Audit or External Audit Accenture, Chennai Dec 2013– Dec 2015

Operation Specialist, Aggregate Safety Reporting

• Conducted all activities per applicable company SOPs, GCPs, ICH regulations and guidelines

• Timely preparation and submission of regulatory documents (ICSR’s and aggregate reports) on regular basis

• Daily submissions of single case adverse event reports and queries by the GPV&E US Submissions Team/ Chennai Operation Specialists

• Submission of cases received for approved products (15 Day Alert reports) or from clinical studies Suspected Unexpected Serious Adverse Reaction (SUSARs)

• Submission of SUSARs – Clinical/Non-Clinical studies

• Submission of Source documents for spontaneous adverse events to Business partners

• Created Structures for Safety Summary report, Line Listing, Investigational SUSAR and SASUSAR, clinical Overview, Non-Periodic Safety Report and Adhoc Reports

• Created publishing profiles, table of contents and document header & footer overlays

• Publishing (Bookmarking and Hyperlinking) different types of documents

• Editing hyperlinks and bookmarks using ISI Toolbox features like Link Attributor, Keyword Linker, Bookmark Attributor, Bookmark and hyperlink Auditor

• Archive certain submissions in Documentum based electronic document management systems

• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents

• Everyday use of ISI Toolbox for submission readiness and assembly Apollo Hospitals, Chennai JUL 2013-DEC 2013

Clinical Research Coordinator

• Observed dossier compilation process for IRB submission, understood the compliancy in regulatory document review, entered analytical data for the BA/BE drug study, observed clinical study, subject care, subject enrollment, on-going clinical study

• Assisting the Principal Investigator in study feasibility assessments as requested

• Preparing other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs

• Establishing and organizing study files, including but not limited to, regulatory binders, study specific source documentation and other materials

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