Quality Assurance Management

PRIYA KARAMBELKAR

*** ********, ***. *, ******, MA 02215 Cellular: 720-***-**** acy3v5@r.postjobfree.com https://www.linkedin.com/in/priyajk

SUMMARY

Analytical, result-oriented and thoughtful pharma professional interested in challenging position in the field of quality, clinical and regulatory affairs.

EDUCATION

Northeastern University, Boston, MA, USA MS in Regulatory affairs for drugs, biologicals and medical devices

Pursuing

(June 2017)

A

(Courses: New drug development, Medical device development, Biologics development, Global biotech product registration, Combination products and convergence, Biomedical product development: from boardroom to market) University of Mumbai, Mumbai, India Master in Pharmaceutical quality assurance Jun 2014 A Bioiformatics Institute Of India, Noida, India Certificate course in Pharma Regulatory affairs Dec 2012 A University Of Pune, Pune, India Bachelors in Pharmacy Jun 2011 A PROFESSIONAL EXPERIENCE

Common Sensing, Cambridge, MA Quality Assurance and Regulatory Affairs Associate Since July 2016

Regulatory affairs

Audit the quality management system against the regulatory requirements of 21 CFR 820

Quality systems

Identify the regulatory requirements of 21 CFR 820 which are applicable to Common Sensing

Write Quality system procedures compliant with regulatory requirements

Communicate regulatory requirements to the responsible personnel

Work with responsible personnel to implement quality management processes which implement the regulatory requirements

Ensure compliance with the quality management system

Report on measured quality systems data for management review

Perform quality systems duties in conformance with established process

Quality assurance

Review engineering work to ensure that it is performed in compliance with existing processes, protocols and plans

Sign off on changes to quality system processes as the quality reviewer

Sign off on design documentation as the quality assurance reviewer

Sign off that components/product meet established specifications

Quality control

Inspect incoming material, in-process product, and finished product in accordance with established specifications and processes

Breegi Scientific, Boston, MA Project intern Apr 2016 – June 2016

Regulatory requirements analysis

Market analysis

Development of business plan

Mylan Laboratories Ltd., Nashik, India Quality assurance officer Apr 2014 – Jun 2015

Performed In Process Quality Assurance activities in various areas of operation ensuring cGMP compliance at all stages of manufacturing in solid dose manufacturing plant.

Monitored qualification and validation activities and performed necessary sampling and testing according to SOP.

Conducted weekly SOP trainings to teammates and also suggested changes to the SOP developing team.

Inspected BPCR and other quality documents for integrity.

Worked closely with deviations, APR, change controls, CAPA and market complaint teams.

Faced Inspections by USFDA, WHO and Medicines control council. Bharati Vidyapeeth’s college of Pharmacy, Navi Mumbai Research assistant Jun 2012- Dec 2013

Formulation and evaluation of a phytosomal drug delivery system made from sugarcane molasses extract. Proved that its bioavailability was improved than that of the extract.

Assisted in various lab studies including HPLC, dissolution, formulation development. Glenmark Pharmaceuticals, Nashik Pharmaceutical Intern Nov 2009

Worked in all departments of Pharmaceutical manufacturing to gain basic idea of their function Sinhgad college of Pharmacy, Pune Project assistant Sep 2008- Feb 2009

Simultaneous Estimation of Hydrochlorothiazide and Telmisartan in a Tablet Dosage Form by UV spectro- photometric method

PUBLICATIONS AND PESENTATIONS

Presentations:

Awareness and Use of Video Games for Rehabilitation and Therapy in Indian Healthcare Centres.

DIA 49th annual meeting,

Boston

Jul 2013

Evaluation of analgesic activity of Tamarindus indicus on albino mice 64th Indian Pharmaceutical Congress, Chennai

Dec 2012

Simultaneous Estimation of Hydrochlorothiazide and Telmisartan in a Tablet Dosage Form by UV spectrophotometric method AVISHKAR - University of

Pune initiative

Dec 2009

Publications:

Needle free injections: the renaissance and technology. Priya J.Karambelkar, Deepthi V.Tatiraju, Varsha B. Bagade, Varsha M.Jadhav, Vilasrao Kadam; IJPRD, 2013, vol. 5 (06), Aug 2013

Painful Diabetic Neuropathy: Mechanisms to Management. Deepthi V Tatiraju, Varsha M Jadhav, Vilasrao Kadam, Varsha B Bagade, Priya J Karambelkar; Journal of Advanced Pharmacy Education & Research, Jul-Sept 2013 Vol 3 Issue 3

Isolation and characterisation of flavonoid Tricin from sugarcane sludge. Priya Karambelkar, Dr. V.M. Jadhav, Dr. Vilasrao Kadam; Indo American journal of Pharmaceutical research, volume 4, Issue 05, 2014.

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