Quality Assurance

Hinal Pittaliya

Iselin, ***** **********@*****.*** 516-***-****

Professional Summary:

Regulatory affairs professional with a great deal of experience working in the pharmaceutical industries. Excellent multi-tasker with ability to work with detail orientation under pressure. With wise communication skills, problem solving is my forte.

Education Profile:

I.Long Island University, NY, USA January, 2016 – Present Master of Science in Drug Regulatory Affairs (3.80 GPA)

II.Gujarat Technological University, LJIP, Gujarat, India August, 2008 – June, 2012 Bachelor of Pharmacy (3.80 GPA)

Skills:

Regulatory: IND NDA ANDA BLA Advertising and Promotion of Drugs cGMP GLP GCP FDA inspections 21CFR Labeling SOPs ICH eCTD U.S. and International Regulations

Computer: MS Office Suite (Outlook, Word, Excel, PowerPoint) Adobe Acrobat

Experience:

Quality and Regulatory Affairs Associate, Aurocare Life Science PVT. LTD., Gujarat, India (January 2013 – December 2015)

oeCTD submissions (ANDA).

oPerform investigation of non-conformance including customer complaints and develop resulting CAPA action plans, change control documentation, promotional materials, MSDS, Annual Product Reports (APR).

oCoordination with vendors, contract manufacturers packaging and shipping of products with best quality support and ensures compliance within regulations.

oMonitored product indexes, batch records and documentation as per the cGMP, GDP norms.

oReview and proofreading of labeling and labeling comparisons intended for submission to FDA according to NLEA (SPL format) (21CFR 201).

Quality Assurance Intern, Unicon Pharma, Gujarat, India (July 2012 – August 2012)

oMonitored estimation of finished products and its labeling and packaged inserts, promotional material for final review.

oWriting of internal work procedure, guidelines, SOPs, protocols quality testing of drugs and parenteral preparations.

oCoordination with vendors, contract manufacturers packaging and shipping of products with best quality support and ensures compliance within regulations.

oReviewed product quality study reports and administrative documents for eCTD submission, maintained database.

oReviewed SOPs for testing and conducted in-Process Quality Control Testing of Tablets and capsules as per SOPs.

Reference: Available upon request.

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