Arpitha Ireddy

**** **** ** *

Plymouth MN-*****

812-***-****

ac2dph@r.postjobfree.com

Self-motivated professional with strong background in analytical chemistry and more than 10 years of experience in Analytical chemistry in a cGMP environment. HPLC,GPC, GC, UV-Vis, Dissolution, pH, Karl Fischer, particle sizing, FTIR and wet chemistry methods, physical and mechanical test methods. Expertise in compendia methods from USP, EP, BP and JP as well as GMP, GLP, ICH and FDA and ISO regulatory standards. Advanced computer skills and use of various software applications, and experience with designing DOE. Always works towards developing self. Experience with combination products, medical devices and adhesive.

Professional Experience:

Sr Chemist

Medtronic, Plymouth, MN

August 2015 – Present

Developing and Validating new R & D Analytical methods.

Developing, improving and validating physical and mechanical test methods.

Responsible for Quality compliance in lab.

Improving existing methods and validating them.

Transferring of methods from other labs.

Validating existing methods.

Optimization of analytical methods.

Performing Analysis using established and R and D test methods.

Optimizing wet chemistry, physical and mechanical test methods for QC use.

Leading method validations and presenting to larger group.

Working on continuous improvement of methods for QC use.

Partner with Quality to develop and improve lab procedures and resolving Quality compliance issues.

Providing Analytical and technical support for process improvement projects.

Managing projects within R & D and cross functionally

Provide technical assistance to different projects with other groups.

Writing Technical Documents.

Maintaining, Troubleshooting and Calibration of Analytical instruments.

Troubleshooting method issues for Analytical, mechanical and physical test methods.

Writing SOPs and other lab safety protocols.

Compliance with Quality System requirements, applicable FDA /international regulatory laws/standards.

Chemist

Covidien/Spectranetics, Maple Grove MN

November 2013 – August 2015

Conduct test method transfer from alternate test labs.

Improve lot release test methods.

Develop stability indicating methods.

Stability testing, routine testing.

Testing for Assay and impurities for combination devices.

Dissolution testing for combination devices.

Troubleshooting instrument and method issues.

Method validation and method development.

Method optimization for QC use.

Write and revise laboratory test methods, procedures, protocols.

Writing Technical documents.

Operation and performing maintenance on instruments.

Compliance with Quality System requirements, applicable FDA /international regulatory laws/standards

Associate Chemist

Medtronic, Rice Creek, MN

November 2010 – July 2012

Complying with all Quality system requirements.

Performing, collection, measurement and record keeping of elution samples.

Performing QC release testing like content uniformity, elution, Assay/Deg products.

Analytical method transfer from other test labs

Method validation

Working on continuous improvement of methods

Helping drive team to meet business goals

Peer review

Learning manufacturing area that lab supports

Analyzing and deducing data and collating test results.

Chemist

3M, St Paul, MN

November 2009 – October 2010

HPLC analysis of array patches and formulations to support ongoing formulation and device development efforts.

Develop new test methods to cater to the needs of formulators.

Turn around results quickly and also accurately.

Peer reviewing.

Document ideas, results in a Technical Lab NB.

Quality control Scientist

KP Pharmaceutical technology, Bloomington, IN

September 2007 – October 2009

Perform accurate and timely analysis of in process and finished product samples according to current analytical procedures, SOP`s and laboratory guidelines.

Perform accurate and timely analysis of stability samples according to current analytical procedures, SOP`s and laboratory guidelines.

Developing, establishing and maintaining analytical testing methodology used to control raw materials, production intermediates and final products.

Author relevant SOPs.

Managing contract analysis at outside labs.

Perform QC release testing, validation testing.

Data review.

Maintenance and calibration of equipments.

Associate Scientist

Natco pharmaceuticals, Hyderabad, India

October 2006 – June 2007

Analyzed samples from various sources to provide information on compounds present using various techniques like HPLC, FTIR etc.

Interpreted data and reported results.

Assisted in equipment calibrations.

Assisted in the synthesis of new reagents for R & D.

Education

Masters in pharmaceutics, Dr MGR University of Health Sciences, Tamil Nadu, India.

Bachelors of Pharmacy, University College of Pharmaceutical Sciences, Warangal, India.

Education Equivalency done in US. Copy attached.

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