Quality Assurance Control

Summary of Expertise

. Comprehensive understanding of FDA's organization and its contemporary

regulatory compliance proceeding processes.

. Ability to develop and assist in the development of a central

compliance program for GMPs which ensures successful examination

results.

. Experience in new drug/biologic registration, regulatory compliance

and quality assurance.

. Ability to prepare IND, 510(K) and BLA applications and conduct

successful submissions to the FDA.

. Experience in establishing and developing regulatory affairs and

Quality

Assurance Systems.

. In-depth knowledge of FDA regulations for GCP's, GLP's and GMP's.

. Ability to make effective use of regulatory intelligence in designing

regulatory strategy for commercialization of product in emerging

markets.

. Knowledge of US and International regulations for regulatory approval

of products and development process of eCTD submissions.

Education

MS in Drug/ Biologics/ Medical Device Regulatory Affairs

(Jan 2010 - July 2011)

(Northeastern University, Boston, MA)

Bachelor of Biotechnology

(August 2005-May2008)

(Hemwati Nandan Bhauguna Gharwal University, Uttrakhand, India)

Professional Experience

Bio-Concept Laboratories, Inc.: Regulatory Affairs Associate and Quality

Assurance Specialist

(Jan 2012-Present)

. Responsible for the creation and maintenance of Regulatory and Quality

documents, including the Site Master File and Quality Manual.

. Responsible for Amendments to IND Filings

. Participate in Regulatory Audits, adhering to SOPs

. Support of Electron Management System for Regulatory Filings

. Write responses for Client Regulatory Audits

. Responsible for Deviations, OOS, and Investigation Reports

. Responsible for performing the biennial review of SOP's.

. Responsible for keeping control over all new documentation and

revisions i.e. SOP, Technical Methods, Templates, Forms, etc.

. Generate Batch records according to client specifications and Aseptic

Fill Manager.

. Responsible for generating a protocol in accordance to the client and

the stability program

. Responsible for conducting and handling an Internal Audit.

. Assist in FDA Audits

Vista Scientific LLC: Intern Regulatory Affairs/Quality Assurance (May

2011- July 2011)

. Responsibility of all the operational features of the Quality

Assurance and Quality Control divisions associated with the

manufacture of products in strict agreement with all SOP's, cGMP's,

company procedures and policies and the FDA requirements for the

manufacture of medical devices.

. Reporting and management of all the activities of the Quality

Assurance and Quality Control Divisions and the assigned officials.

. Responsible for the preparation of 510(K) applications for submission

to the FDA.

. Responsibility for the conduction, coordination and documentation of

investigations, CAPA actions and the maintenance of records.

. Responsible for ensuring that the final products are tested for

acceptability as per the written procedures

. EDC, SCADA, DCS, Custom and validation applications. Process

Equipment, Manufacturing, Utilities, and Engineering.

Projects

. Regulatory Plan for Combination Product Approval - Pancreatic Cancer

. IND and BLA Submission

. Drug Manufacturing End of Phase 2 Meeting Application

. Pharmaceutical Manufacturing in India

. Development of CAPA

. Warning Letter Reply

. Packaging and Labeling

. Isolation of Genomic DNA from the leaf extracts of Rosa rouxburghii

. Paper presentation on the topic isolation of genomic DNA from the leaf

extracts of Rosa rouxburghii

Accomplishments

. Experience in the analytical techniques like HPLC, HPTLC, GC, UV-Vis

Spectroscopy.

. Computer Skills: MS Office, Word, Excel, PowerPoint.

. Certificate of social services received from the organization "Help

Age India" for spreading awareness and assisting in raising funds for

the care of elderly, irrespective of caste and creed.

. Certificate received from the National Level Conference on Microbial

Diversity in the year 2007.

. Certificate of Appreciation received for participating in the Lions

International Peace Poster Contest.

. Certificate of attendance from the FDA webinar on the Structured

Product Labeling (SPL).

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