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Nikita Deshpande [email protected] • 732-762-8434 Summary Professional with over two years of experience in Regulatory Affairs and Quality Assurance with expertise in technical writing, training, investigations, audits, and regulatory submissions. Professional Experience Associate, Quality Assurance and Regulatory Affairs (Oct. 2015 – Present) Sigmapharm Laboratories, Bensalem, PA • Author Standard Operating Procedures (SOPs), Quality System Manual, Quality Policy, and Audit Reports. • Develop SOP training program, metrics, and comprehensive assessments. • Impart cGMP and SOP training. • Review ANDAs, annual product reports, annual product reviews, and drug product labeling for FDA submissions. • Evaluate product complaints for filing Field Alert Reports (FARs) with the FDA. • Investigate product quality complaints, out of specification results (OOS), out of trend (OOT) results, and deviations. • Ensure product recalls, product and facility registrations are documented. • Prepare trend analysis reports to monitor compliance and aid inspection readiness. • Participate in internal and vendor audits. • Provide CAPAs and monitor their implementation. • Issue, review, and approve change control documents, batch records, and vendor change notifications. • Performed in-process quality control checks during manufacturing operations. • Sample incoming raw material, in-process, and finished products for analytical testing. • Review and approve analytical method validation protocols and reports, specification sheets, and monographs. • Review and approve analytical reports for release of raw material and finished product. • Review stability protocols and summary reports for finished products. • Review Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment. • Archive all the documents in compliance with Good Documentation Practices (GDP). Regulatory Affairs Professional (Jul. 2014 – Jun. 2015) Altria Client Services, Richmond, VA • Collaborated in the development of a database to monitor the deeming regulation for tobacco products. • Assisted in compiling meeting packages for scientific information meeting with the FDA. • Analyzed Establishment Inspection Reports (EIRs) to identify FDA audit trends to inform the company’s audit capabilities. • Performed literature review to support the Modified Risk Tobacco Product (MRTP) applications. • Compiled a report on the FDA Drug Supply Chain Security Act to find its potential relevance to the tobacco industry. • Assisted in developing quality agreements and supplier agreement templates. • Participated in regulatory strategy planning and intelligence data mining. Regulatory Intern (May 2012 – Jun. 2012) Flamingo Pharmaceuticals, Mumbai, India • Compiled e-CTD submissions for various regulatory authorities globally. • Reviewed labels, drug master file (DMF), master formula records (MFRs), and batch manufacturing records. • Contributed in archiving quality documentation, marketing approval, and SOPs. Education Master of Science in Regulatory Affairs (Sep. 2013 – Aug. 2015) Northeastern University, Boston, MA Bachelor of Pharmacy (Sep. 2009 – May 2013) University of Mumbai, India Special Skills • Trained in cGMP, GLP, GDP, and GCP. • Competent in Title 21 CFR Part 210 and Part 211. • Proficient in Microsoft Office programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat.
