Current Location: Morgantown, WV

EDUCATION:

New Jersey Institute of Technology New Jersey, USA Sep 2012 – Jan 2014

Master of Science in Biomedical Engineering, GPA: 3.5/4

Anna University Tamil Nadu, India July 2008 – May 2012

Bachelor of Engineering in Biomedical Engineering, GPA: 8.5/10 (Distinction)

SOFTWARE SKILLS:

SAP, Documentum, TrackWise, LIMS, CARA, Matlab, LabVIEW, ANOVA, Minitab, MS office.

PROFESSIONAL EXPERIENCE

Synopsis:

Proficient in Quality non-conformance investigations and served as the Subject Matter Expert (SME) for all Manufacturing departments.

Ensured Quality Compliance by performing risk assessment, historical evaluation (trending) of nonconformities and implementing adequate preventive measures (CAPAs) to eliminate recurring manufacturing deviations.

Planned and coordinated activities with Manufacturing and Quality for critical decisions to support site deviations.

Provided Quality oversight for Validation (IQ, OQ, PQ), Calibration, Maintenance and troubleshooting problems related to production equipment, process controls and facility measurement systems.

Made Quality and Product Release decisions on a regular basis by interacting with cross-functional teams like Quality, Regulatory, Manufacturing, Maintenance and Safety to facilitate production.

Conducted internal audits to identify problem areas and developed strategies for process improvement and optimization using Process Capability and Operational Excellence techniques.

Tracked and reported key performance metrics (including Right First Time) of the unit operation and provided technical oversight to ensure schedule adherence and cycle time reduction.

Technical Area Lead

Mylan Pharmaceuticals Inc. March 2014 - Present

Performed several investigations using Root Cause Analysis tools (5Y, fishbone, 5ME) for process failures/deviations to assess the product impact in unit operations.

Owned, implemented and ensured the effectiveness of several CAPAs and action items in a timely manner.

Completed several Change Controls to facilitate a compliant Quality System.

Responsible for reviewing and approving several CAPAs and investigations through the TrackWise system.

Authored, reviewed and approved Standard Operating Procedures (SOPs) and controlled documents to suit GDP & GMP requirements.

Provided guidance and training to new hires related to the process, facilities and Quality systems.

Periodically reviewed formula sheets and auxiliary documentation to ensure Good Documentation Practices (GDP).

Supervised manufacturing operations and managed a team of 25 manufacturing employees to ensure Good Manufacturing Practices (GMPs) and safety regulations are being observed at all times.

Followed DEA guidelines on the security, storage, handling and manufacture of scheduled drugs.

Created a tracking and trending mechanism to document 6S trends and employed Lean Manufacturing methods in order to identify and drive Kaizen events throughout the department.

Internship

Integrated Bio-Medics & Technology (IBMT) April 2010 – June 2010

Hand on experience in the internal circuits of various physiotherapy equipment

Assisted the Biomedical Engineer in troubleshooting several healthcare equipment problems

Assisted the Maintenance engineer with the maintenance of physiotherapy and ICU equipment

Performed risk assessments to identify and designate Customer Complaints based on Risk Priority

ACADEMIC PROJECTS

Masters Thesis, New Jersey Institute of Technology Jan 2013 – Jan 2014

Fabrication of electrospun nanofiber mats using soy-based natural and renewable materials

Biocompatible nanofiber mats were fabricated by the process of electrospinning using soy protein isolate and various natural and renewable blend polymers like gelatin, carrageenan and sodium cellulose sulphate.

Interaction between human fibroblast cells and the nanofiber mats were studied.

Projects, New Jersey Institute of Technology

Design of a novel scaffold in cartilage tissue engineering using a chitosan-based hyaluronic acid biomaterial conjugated with BMP-2

Design, fabrication and testing of microfluidic devices

Projects, Anna University

Early detection of cardiovascular disease based on Heart Rate Variability analysis

Iris image based medical diagnosis system

Presentations and Publications:

International Conference presentation - ‘A Neural Network Classifier for Early Detection of Cardiovascular Diseases Based on HRV Analysis’ at the International Conference on Mathematical Modeling and Applied Soft Computing.

National Level Symposium - ‘Liquid Bio Fuels’ at the symposium held at Agricultural Engineering College and Research Institute, Coimbatore.

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