Quality Control Project

VAIBHAVI C. SHETYE

**** ******* ******, ***. *, Monroe, LA 71203 318-***-**** *****************@*****.**.** LinkedIn

Account: Vaibhavi Shetye

Summary

Qualified Pharmacist (India) holding a Bachelor of Pharmacy while currently pursuing an MBA. Capable of

independently performing Analytical Method Validation and Method Development activities on drug products and

drug substances. Possess hands-on experience in equipment/software qualification as well as event and deviation

handling in a GMP compliant environment. Equipped with analytical thinking, independent project handling and

project coordination skills.

EDUCATION

Masters in Business Administration and Management (GPA 3.5) Anticipated December 2014

University of Louisiana at Monroe, Monroe, LA

Post-Graduate Program (GPA 3.5) 2010 – 2011

Industry Pharma Regulatory Affairs

Bioinformatics Institute of India

Bachelor of Pharmacy (GPA 3.24) 1998-2002

Bombay College of Pharmacy, University of Mumbai

INTERNSHIP EXPERIENCE

Pharmacy Intern October 2001 – November 2001

Bayers India Ltd., Mumbai, India

• Cleaning validation of the equipments used for production of anti-hypertensive tablets

• Gaining knowledge of production and quality control process in the organization

PROFESSIONAL EXPERIENCE

Graduate Student January 2013 – Current

College of Business Administration, University of Louisiana at Monroe, Monroe, LA

• Working on evaluation of Information Security Systems in Healthcare industries

• Well verse with Statistics & Quality Control

• Knowledge of Financial & Managerial accounting, Financial Analysis, Operations Management

Senior Officer (Analytical Development) October 2009 – January 2013

Janssen Pharmaceuticals (Johnson & Johnson ltd.), Mumbai, India

• Coordinating with the project leads for the execution of the project at the site

• Proving bioequivalency of developed dissolution methods

• Training the trainees on method development and GMP practices

• Life cycle management of laboratory computer systems and related incident handling

• Preparation of analytical specifications, methods and protocols for registration stability studies

• Knowledge of using electronic lab notebooks

Officer (Analytical Development) April 2008 – October 2009

Janssen Pharmaceuticals (Johnson & Jonson ltd.), Mumbai, India

• Experience of raising change control in GMP environment

• Prepared and reviewed qualification protocols and performed risk assessment of analytical instruments

• Experience of Data review in GMP environment

• Exposure of audits like US FDA, EMEA and other site audits

• Experience of developing analytical methods for pre-clinical and early clinical trials

• Exposure to develop and validate analytical methods for large molecules

• Prepared development reports, SOPs and validation protocols

Assistant Officer (Analytical Development) July 2005 – April 2008

Janssen Pharmaceuticals (Johnson & Johnson ltd.), Mumbai, India

• Performed registration stability on IND/CTA, NDA/MAA drug products

• Exposure of independently developing analytical (stability indicating) methods on HPLC, UPLC, Dissolution,

Karl Fischer autotitrator and gas chromatography

• Exposure of analytical method transfers and AMERTs of NME

• Exposure of performing documentation as per GMP requirement

• Knowledge of Handling OOS, OOT, deviation and OOW as per US and EU guidelines

• Have experience of performing validation/qualification of computerized systems as per 21 CFR part 11 and

EU guidelines

• Exposure of working with LIMS systems for data entry

• Experience of performing instrument/ equipment qualification

Research and Development Scientist February 2004 – June 2005

Cipla Pharmaceuticals Ltd., Mumbai, India

• Technology transfer of Analytical laboratory methods on HPLC, UV & Dissolution

• Exposure to perform forced degradation studies

Research and Development Trainee February 2003 – February 2004

Cipla Pharmaceuticals Ltd., Mumbai, India

• Method development & Method Validation of ANDA formulations

• Calibration & Qualification of Laboratory instruments

• Developmental stability studies on various dosage forms and APIs

PROFESSIONAL ACHIEVEMENTS

• Felicitated by Global Head (Johnson & Jonson, Ltd.) on the successful completion of a prestigious project

before the stipulated time lines and for good coordination with the US counterpart

• Recommended by associate director of Centocor PA-US for a cash prize on the successful completion of a

project and received the same

• Received a cash prize for successful analytical method development on Hepatitis C formulation

• Rated by Johnson & Johnson, Ltd. as a one of the top 25% most efficient employee for four years (above 7 on

the scale of 1-9) for exceptional performance

• Have given the following presentations:

--Empower2 software functions and usage

--Instrument validation and software qualification as per 21 CFR Part 11 guidelines

--Instrumentation and application of Volumetric Karl Fischer titrations

REFERENCES

Available Upon Request

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