Six Sigma Engineer

Ankit M. Chovatia

Email: ***********@*****.*** | (M):857-***-****

OBJECTIVE:

Seeking full time/contract position within Pharmaceuticals/Biopharmaceutical Industry

SKILLS:

Analytical skills: UV/Visible spectrophotometer, HPLC, Paper chromatography, GC, TLC, PH Meter, Wet Chemistry

Laboratory Software: M-files, Minitab (Expert with Gage R & R, DOE, Graphical Interpretations), TrackPro, InFlow

Quality Skills: 21 CFR Part 210 & 211, 21 CFR part 11, CAPA, GMP, GLP

Validation: IQ,OQ,PQ, Cleaning Validation, Process Validation, Calibration, Risk Management tools (FMEA, CAPA, Fishbone Chart),Validation Protocol, VMP and Report Writing and execution

Manufacturing: Lean and Six Sigma basics, Design of Experiments, Quality by Design (QbD), Statistical Process Control (SPC) Tools (Histogram, Pareto Charts, Control Charts, Cause and Effect Analysis)

EXPERIENCE:

Stevens Pharmaceutical Research Centre (SPRC), Hoboken, NJ, USA October 2010 – May 2012

“Solvent Interference Study on TOC Analyzer”

• Collect, compile, analyze and interpret the data about the interference of the organic solvent on the TOC analyzer.

• Statistical and graphical analysis using Minitab.

• Prepared and maintained laboratory documents, Batch Record and/ or SOPs as required by regulatory compliance.

• Reviewed the documents such as batch records, log sheets for verifying the activities that has been performed.

• Expert in Technical documentation writing, SOPs, Validation Protocol, VMP and Reports according to cGMP regulations.

• Assist the team for deviation investigation by FMEA for resolution of problem.

• Trained on GMP, SOP, HPLC, TOC, Swab Sampling and Laboratory safety.

Validation Project Engineer

Expert in process/product development, Equipment Calibration, Qualification, Validation and Commissioning

Mechanical Engineering Department, Stevens Institute of Technology, Hoboken, NJ

Graduate Assistant July 2011 – June 2012

Kaptab Pharmaceutical, Vadodara, Gujarat, India

Trainee May 2008 – July 2008

• Experience with raw material, API, Intermediates and final product testing.

• Expert in Inspection of tablet for stability, dissolution, disintegration, drug release and tablet specifications with standard data and generation of batch reports.

Rise Remedies Ltd. Vadodara, Gujarat, India

Manufacturing and Quality Control Trainee May 2009–August 2010

• Performed assays as per cGMP compliances based on existing methodologies.

• Operated analytical instruments such as HPLC, UV/VIS, GC, MS to analyze raw materials, production intermediates and final products. Familiar with pH-meter, Karl-Fischer titration and other techniques of wet chemistry.

EDUCATION:

Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing GPA: 3.70

Graduate Certificates: Validation & Regulatory Affairs, Pharmaceutical Manufacturing Practices

M.S. University of Baroda, Vadodara, Gujarat, India

Bachelor of Pharmacy GPA: 3.63

PROFESSIONAL AFFILIATION:

Member of International Society of Pharmaceutical Engineering – ISPE-Attend Six Sigma workshops.

Stevens Pharmaceutical Research Centre – SPRC-Certified Analyst for Total Organic Carbon Analysis

LinkedIn Profile: http://www.linkedin.com/pub/ankit-m-chovatia/27/289/6aa

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