Computer Science Professional Experience

Summary:

Accumulated experience of **+ year in Technical Writing and Reviewing. Knowledge of cGMP, ICH, USP, FDA guidelines and submitted more than 30 ANDA. Research, develop and document technical test scripts (Method Validation & Verification Protocols) and Reports and design specifications. Ability to learn new things, work under time pressure to meet deadlines. Able to work independently or in team and can manage multi-projects in a cross functional environment with prioritizing work. Strong aptitude in problem solving, process improvement, statistical engineering, analytical and quantitative techniques.

Education:

Ph D – Studies on Computer Oriented Optimization Techniques,

Sardar Patel University, India

Diploma in Computer Science,

Sardar Patel University, India

Master of Science (Mathematics),

Sardar Patel University, India

Bachelor of Science,

Sardar Patel University, India

Skills:

Strong technical ability on MS Word, MS Excel and MS Power Point

Ability to write / modify / link on Adobe Acrobat (electronic publishing/eBook)

Command on document management system - Master Control (electronic document authoring, reviewing, and approval process)

Working technical knowledge on VeevaValts and ComplianceWire

Successfully worked on design of Mathematical and Statistical modeling

Strong aptitude to DoE, Ishikawa, FMEA, Regression modeling, Hypothesis testing, Control Charts, Box-plot, CE matrix, Capability index, etc

Experience on Statistical Tools Minitab and JMP including DoE analysis

Technical skills for designing and developing in-house software using MS Excel

Working knowledge of programming languages R and Python; Databases (SQL) and data science, analysis and MS Powder BI.

Professional Experience:

Impax Labs, Middlesex, NJ (Formally Core Pharma) January 2005-July 2017 Technical Writer III (Analytical R&D Generic Pharmaceutical)

Major responsibilities include:

Research, Organize, Write and Review technical regulated documents for ANDA submission:

Standard operational procedures (SOP)

Method Validation & Verification Protocols and Reports

Method Transfer Protocol / Reports

Investigation/Deviation/CAPA Report

Cleaning Validation Protocols and Reports

Analytical Methods / CoA / Specification

Quality Overall Summary and QbD of the product per FDA guidelines

Change Control Request, Routing and Disposition

Support to Formulation R&D work

Data Analysis and Data Science:

DoE and statistical data analysis using Minitab and in-house software

Review R&D and cGMP (QC/LTS) work

Strayer University – Piscataway and Basking Bridge, NJ March 2011 – Present

Adjunct Faculty (Mathematics and Computer Information System)

Courses taught at Graduate (MBA) Level:

Business Statistics: Emphasized on problem solving and process improvement methodology

Quantitative Methods: Emphasized on solution optimization methodology

Simulation and Modeling: Emphasized on mathematical modeling

Courses taught at Undergraduate Level:

Information System: Emphasized on fundamental of information system

System Analysis and Design: Emphasized on tools and techniques on system design

Algebra: Developed skills on thinking, logic, patterns, problem solving and reasoning

Guided and Graded Case Studies / Term Papers

Sardar Patel University, Vallabh Vidyanagar, India (1983-2004)

Professor and Head/Dean

Responsible to supervise the academic programs for Computer Science / Mathematics at graduate level

Associate Professor

Responsible for the development of courses and laboratory work on various courses on Operations Research and Computer Applications

Assistant Professor and Computer Lab Supervisor

Responsible for the development of course material on computer and mathematical modeling and computer lab management

Visa Status:

USA Citizen

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