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Quality Control Project Management

Location:
Fremont, CA
Posted:
September 21, 2017

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Resume:

PRASHANT PATEL

TECHNICAL SKILLS

Organized

Analytical Chemistry

Quality Control

R&D

Organic Synthesis

GC ChemStation Software

HPLC

LC-MS

GC-MS

TLC

IR Spectroscopic basic

Viscometer

Centrifugation

Autoclave

Lab setting skills

Laboratory, Manufacturing, and Plant Safety

QC and Testing Skills

Chemdraw Ultra 8.0

Ullmann’s Encyclopedia

Reaxys

Product Cycle Management

Excellent Communication Skills

MS Office

MS Project

MS Visio

Lucid Chart

SharePoint

Project Management (Agile)

SAP ERP

SQL

SAS (Basic)

ACADEMIC CREDENTIALS

M.B.A -2015-2016

Northwestern Polytechnic University-CA, US

M.Sc. (Organic Chemistry) - 2011-2012 Sardar Patel University

B. N. Patel Institute of Science & Paramedical, Anand-388001, Gujarat, India.

B.Sc. (Chemistry) - 2007-2010

Sardar Patel University

V.P & R.P.T.P. Science Collage, Vallabh Vidyanagar-388120, Gujarat, India

Work Experience

Business Analyst

Palo Alto Mgmt. LLC-CA, US

Aug-2016 to May-2017

Practical knowledge of Waterfall & Agile as iterative SDLC methodology with implementation of all phases: Inception, Requirement Gathering, Designing, Development, Testing, Deployment, and Maintenance.

Project management experience involves delegating responsibilities, budgeting, designing time schedules and work breakdown structures (WBS), preparing weekly status reports for management, communicating and presenting the reports, and resolving issues and conflicts.

Involved in Data Validation, Data Cleaning, Data Imputation and Data Transformation techniques.

Quality Control Chemist

Sun Pharma Limited-GJ, IN

Dec 2013 to Jan 2015

Operational experience GC, HPLC and Cham-station software.

Perform routine analytical testing for in-process and finished products.

Perform routine analytical testing for raw materials, special test requests, laboratory investigations, and instrument qualifications according to validated

methods.

Data documentation of tests and results using Empower software and LIMS as well as data review.

Collects, analyzes and reports data and results according to GDP, regulatory and local requirements.

Support manufacturing process control & process improvement projects.

Review of analytical test procedures as required.

Performs routine lab maintenance, special projects, and other duties as assigned.

Troubleshoots and calibrates instruments and equipment as required and maintains good laboratory safety and general housekeeping.

Manage inventory and documentation for standards and controls.

Sr. Research cum Quality Control Chemist

GHPC Limited-GJ, IN

May 2011 to Nov 2013

Experience in using GC, HPLC, UV, Karl Fisher and other related analytical technologies.

Conducted analysis starting from raw material to finished products.

Prepared, standardized and maintain chemical reagents and solutions to be used in analysis.

Hand on experience with PH testing, FTIR and other analytical techniques.

Sampling and inspecting of raw materials, intermediate and finished products with proper labeling and also prepare COA (Certification of Analysis).

API Finished products Stability and excipient testing experience.

Performed diligently laboratory analysis correctly for whole project, physical, and chemical analysis.

Compile, summarize and effectively communicate technical results and data

Ensuring site readiness for FDA follower companies to audits by strong emphasis on cGMP/GLP Regulations.

Updated the quality records as per ISO 9001:2000 compliance.

Experienced to Preparing and working on SOPs.

Performing in-house equipment’s calibration and preventive maintenance (PM) or arrange calibration/PM services of equipment’s.

Performed Validation, Calibration and preventive maintenance of laboratory equipment’s and glass wares.

Batch to Batch making samples with proper result and labeling of finished product for vendors.

Perform multi-step synthesis of organic molecules with range of R&D projects and its derivatives including Petrochemicals, API, Fine Chemicals, Pesticides, polymers and many others.

Develop or discover new product from different projects.

Investigated batch-to-batch discrepancies such as Out-of-specification (OOS), deviation and assisted identifying the root cause of such discrepancies.

Prepared day to day & Batch to Batch result of records and generating batch wise reports as well as percentage of purity wise reports.

Extensive hand-on experience with all type of distillations like Vacuum distillation, Fractional distillation etc.

Design and methodically conduct experiments, accurately record data, analyze and compile results and data presentation.

Experience with Method Development and method transfer.

MSDS/SDS coordinator and authoring.

Q.C Chemist

Sima Products-MH, IN

April 2009 to Jan 2011

Hands on experience in using GC, HPLC, UV, Karl Fisher and other related analytical technologies.

Wet chemistry techniques- Titrations, TLC plate, Conductivity, pH meter, Identification tests etc.

Experience in analyzing and testing quality control samples: including raw material, finished product, in-process batch and stability samples by following approved test methods, standard operating procedures (SOP) and specifications per cGMP/GLP regulations.

Raw material testing in accordance with compendia: USP/NF, EP monographs.

Documentation and test reports per good lab practices; Analytical Report Forms and Certificates of Analysis.

Performed specialized and routine analytical testing, development and validation of analytical methods for raw materials and finished products, maintenance of a laboratory notebook, and generation of reports in summary of analytical data.

Peer-review of analytical data generated by other analysts in the quality control per in-house methods and SOP’s.

Prepare report of projects and also submitting product complaints to the Quality assurance department.

Sample shipping to Contract labs and data review.

CONVENTIONS

• “Industrial Motivation Campaign Jointly Ministry of Micro Small Medium Enterprises” at V.P. & R.P.T.P Science College, Vallabh Vidyanagar, GJ, IN-2011

•”International Year of Chemistry” Projects

At V.P. &R.P.T.P Science College, Vallabh Vidyanagar, GJ, IN-2012

•Convention on Pharmaceutical Ingredients (CPHI-PMEC) at Bombay Exhibition Centre, Bombay, IN -2011 to 2014



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